Through a curated team of the world's most experienced and qualified dieticians, performance coaches, scientists, and medical professionals who are subject matter experts in their respective fields, Cizzle Brands is building a house of brands in the sports nutrition industry that serves the world's most elite athletes and leverages that knowledge to make products for everyday people looking to live healthy, active lifestyles. Cizzle Brands' ambassadors will not only assist in product development and formulation but they will also help to expand knowledge and adoption of Cizzle Brands' products around the world.
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Cizzle Brands: A Sports Nutrition Company Leading the Next Wave in Health and Wellness
Cizzle Brands (CBOE:CZZL) is a sports nutrition company driving transformative change within the health and wellness industry. The company commenced trading on CBOE Canada on December 30, 2024, marking a significant milestone in its growth trajectory.
Cizzle Brands leverages deep-rooted connections in the professional sports sector by collaborating with elite athletes to trial and refine health and wellness products to ensure optimal performance, while still being appropriate for athletes of all ages. The CWENCH Hydration products underscore its commitment to premium-quality offerings.
Through Cizzle's broad-based grassroots programs, more than 12,000 youth athletes across North America are sponsored by Cizzle, featuring CWENCH logos on their helmets, jerseys and water bottles.
Company Highlights
- Cizzle is dedicated to driving transformative change in the health and wellness industry by offering premium, clean-label sports nutrition products.
- The companycollaborates with elite athletes and professional sports teams to trial and refine its product offerings, ensuring optimal performance.
- Its flagship brand - CWENCH Hydration - is one of the fastest-growing hydration products in the world, with endorsements from top athletes like Nathan MacKinnon and Andrew Wiggins, as well as up-and-coming superstars Gavin McKenna and Chloe Primerano. Wiggins is also a significant investor in the business.
- The company generated $5 million dollars in net sales in its first 6 months of operations with a gross margin of 60% and is projected to generate net sales of $13 to $15 million in its first fiscal year.
- Driven by a well-defined growth strategy, the company is expanding distribution through major retailers, international market entry, and potential strategic acquisitions to drive revenue growth and market penetration.
- Cizzle’s executive team has extensive experience in CPG, brand building and public markets, including former executives of BioSteel and DreamWater.
This Cizzle Brand Corporation profile is part of a paid investor education campaign.*
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Cizzle Brands Corporation
Investor Insight
Through its innovative line of diversified products, Cizzle Brands Corporation is well-positioned to capitalize on the global MAHA (Make America Healthy Again) movement sweeping the nation. This includes increased consumer demand for low-sugar, high-quality functional foods and beverages, nutritional supplements and sustainable packaging.
Overview
Cizzle Brands Corporation (CBOE:CZZL) is a dynamic sports nutrition company dedicated to driving transformative change within the health and wellness industry. Cizzle commenced trading on CBOE Canada on December 30, 2024, marking a significant milestone in its growth trajectory.
Leveraging deep-rooted connections in the professional sports sector, the company collaborates with elite athletes to trial and refine its health and wellness products to ensure optimal performance, while still being appropriate for athletes of all ages. Its CWENCH Hydration line of products underscores its commitment to premium-quality offerings.
Cizzle maintains a global R&D innovation team involving top nutritionists, dieticians and strength coaches to develop cutting-edge products and bring them to market. This approach ensures that each product is designed to meet the highest standards of performance and wellness.
As consumers become increasingly health-conscious, there is a significant shift toward products that offer clean ingredients and functional benefits, such as hydration, recovery and natural energy. The functional beverage market size is estimated to reach US$229.75 billion in 2025, and is expected to climb to US$329.68 billion by 2030, at a CAGR of 7.49 percent. This growth is driven by rising disposable incomes, heightened awareness of physical well-being, and the growing popularity of fitness lifestyles.
CWENCH Hydration is already recognized as one of the fastest-growing hydration products in the world. In its first 6 months of operation, it generated net sales of $5 million with gross margins of 60 percent and is on track to achieve $13 to $15 million in sales in its first fiscal year. Since its launch, CWENCH has been endorsed by elite athletes and adopted by professional sports teams across North America.
Cizzle is led by a seasoned executive team with extensive experience in consumer-packaged goods, brand building and public markets.
Market Differentiator
Cizzle differentiates itself by developing aspirational products consumed by aspirational people that drive awareness in key markets. Through its broad-based grassroots programs, over 12,000 youth athletes across North America are sponsored by Cizzle, featuring CWENCH logos on their helmets, jerseys and water bottles.
As Cizzle's products develop loyal followings in key markets, other consumer groups are pulled into engagement with its brands. With so many youth athletes making CWENCH Hydration their preferred sports drinks, pantry-loading parents who support sugar-free, all-natural alternatives for their kids become advocates - and ultimately consumers of CWENCH.
Cizzle's commitment to sustainability is another key differentiator. By adopting eco-friendly packaging solutions such as Tetra Pak, the company significantly reduces its environmental impact compared to traditional materials. It also limits the amount of plastics that touch Cizzle's products, minimizing the risk of exposure to microplastics. This move not only addresses growing consumer demand for healthy and sustainable products but also reinforces Cizzle's brand values.
Well-defined Growth Strategy
Too often emerging CPG companies grow faster than their capitalization and infrastructure can support, leading many to flame out or incur dilutive financings. Cizzle is focused on maximizing shareholder value through sustainable revenue growth, strong gross margins, profitability and strategic acquisitions.
As brand awareness grows, and velocity through current retailers accelerates, the company plans to increase sales by expanding distribution channels through major Canadian retailers to boost market penetration and drive product visibility in high-traffic retail locations.
At the same time, Cizzle is building brand awareness and driving sales in select US and European markets where it can drive velocity while maintaining gross margins.
Product innovation is a key pillar of Cizzle’s growth strategy. The company has or is preparing to launch multiple new products across various consumer channels in 2025, including CWENCH Protein and Spoken Nutrition, among others. Each product launch will be supported by targeted marketing campaigns, in-store activations, and influencer partnerships to create brand awareness and drive consumer demand. Furthermore, Cizzle is actively pursuing opportunities to acquire young, innovative companies in the health and wellness sector that align with its mission, thus accelerating portfolio expansion.
Company Highlights
- Cizzle is dedicated to driving transformative change in the health and wellness industry by offering premium, clean-label sports nutrition products.
- The companycollaborates with elite athletes and professional sports teams to trial and refine its product offerings, ensuring optimal performance.
- Its flagship brand - CWENCH Hydration - is one of the fastest-growing hydration products in the world, with endorsements from top athletes like Nathan MacKinnon and Andrew Wiggins, as well as up-and-coming superstars Gavin McKenna and Chloe Primerano. Wiggins is also a significant investor in the business.
- The company generated $5 million dollars in net sales in its first 6 months of operations with a gross margin of 60 percent and is projected to generate net sales of $13 to $15 million in its first fiscal year.
- Driven by a well-defined growth strategy, the company is expanding distribution through major retailers, international market entry, and potential strategic acquisitions to drive revenue growth and market penetration.
- Cizzle’s executive team has extensive experience in CPG, brand building and public markets, including former executives of BioSteel and DreamWater.
Key Products & Brands
CWENCH Hydration
Cizzle’s flagship product, CWENCH Hydration, is a sugar-free, all-natural sports drink formulated with 6+ essential electrolytes and only 10 calories per serving. It stands out with eco-friendly Tetra Pak packaging and no preservatives. Endorsed by high-profile athletes like Nathan MacKinnon, Andrew Wiggins, Gavin McKenna and Chloe Primerano, CWENCH has gained traction in major retail outlets across Canada and select US markets. Its rapid market adoption has solidified it as one of the fastest-growing products in its category.
CWENCH Protein
CWENCH Protein, a post-workout recovery solution, comes in both whey and vegan options. Available in chocolate and vanilla flavors, it leverages the existing CWENCH distribution network to ensure broad reach.
Spoken Nutrition
Spoken Nutrition is a premium supplement line designed to enhance athletic performance and overall wellness by unlocking the expertise behind the world's best athletes. Developed in collaboration with elite trainers and scientists to make products that work, the range includes 14 SKUs targeting various health benefits. A standout product, Sleep Builder, has received significant acclaim for its positive impact on recovery and sleep quality. Spoken Nutrition primarily targets direct-to-consumer channels, elite training facilities and partnerships with celebrity trainers.
Management Team
John Celenza – Chairman & Chief Executive Officer
John Celenza co-founded BioSteel Sports, where he played a pivotal role in scaling the business within the consumer goods sector. His expertise in brand development and market expansion is instrumental in guiding Cizzle's strategic direction.
Tucker Wright – President & Chief Revenue Officer
Tucker Wright brings a wealth of experience from leadership roles at DreamWater and BioSteel. His proficiency in revenue generation and market strategy supports Cizzle's growth initiatives and market penetration efforts.
Anthony Mila – Chief Marketing Officer
Anthony Mila, formerly CEO of HighRise Marketing and CMO of BioSteel, has a strong background in marketing within the health and wellness industry. His strategic vision drives Cizzle's brand positioning and consumer engagement.
Blane Kaufman – Chief Operating Officer
Blane Kaufman previously led operations at BioSteel, bringing extensive operational expertise to Cizzle. His focus on operational efficiency ensures the seamless execution of the company's strategic plans.
Steven Tschirhart – Chief Financial Officer
Steven Tschirhart, who spent over a decade at Kraft Heinz ultimately as Head of Coffee Canada, oversees the financial operations of Cizzle, ensuring fiscal responsibility and strategic financial planning to support the company's growth objectives.
Andy O'Brien – Chief Performance Officer & Director
Andy O’Brien is a legendary sports performance coach who has collaborated with world-class athletes and elite trainers. His expertise contributes to the development of Cizzle's performance-oriented products.
Cizzle Brands Unveils its Team of Ambassadors to Accelerate North American Commercialization Initiatives
Cizzle Brands Corporation (Cboe Canada: CZZL) ( the "Company or "Cizzle Brands") , today unveiled the lineup of subject matter experts ("SMEs") who will underpin the Company's product commercialization efforts for 2025 and drive awareness for its lineup of sports nutrition brands. The Company's roster of SMEs includes some of the world's most experienced and respected strength and performance coaches, dieticians, and medical professionals.
In its Market Introduction press release, Cizzle Brands detailed the performance of CWENCH Hydration™ following its launch in late May of 2024, following which more than one million ready-to-drink units of the beverage have been sold across North America. On January 14, 2025 , Cizzle Brands also announced the launch of Spoken Nutrition , a brand of athlete-grade supplements and nutraceuticals primarily sold through trainers and coaches.
As Cizzle Brands continues to commercialize these product offerings alongside upcoming additional brands to be launched, the Company expects its SMEs to play a key role in product innovation and generating broad-scale awareness in product categories that tend to have very nuanced and knowledge-driven exploration journeys prior to trial or purchase.
Cizzle Brands' current roster of SMEs includes:
Carl Bergstrom: Carl is the Director of Performance for Stephen Curry and former Performance Coach of the Golden State Warriors, White Caps FC, and Canada Soccer.
Dr. Matt Frakes: Dr. Matt Frakes, Assistant Athletic Director of Sports Nutrition at LSU, has prior experience at Notre Dame and the University of Louisville, and holds a PhD in Nutrition and Hospitality Management from the University of Mississippi, along with a Master's and Bachelor's in Food and Nutrition.
Todd Herman: Todd Herman, with over 28 years of experience coaching elite athletes, entrepreneurs, and business teams on inner game, strategy, and performance, is a leading expert on mental game and peak performance, authoring books, building programs, and creating tools to help ambitious individuals succeed across various fields. Todd is the renowned performance coach who helped Kobe Bryant create the Black Mamba.
Ben Prentiss: Ben Prentiss, a strength coach with over 20 years of experience, has worked with professional and Olympic hockey players, including Stanley Cup winners and NHL All-Stars, and currently serves as a Strength and Conditioning Consultant for the New York Rangers.
Carley Patterson: Carley Patterson is a Registered Holistic Nutritionist with a Bachelor of Applied Science, with an expertise in providing nutritional advice to families with young athletes living a competitive and active lifestyle.
Matt Price: Matt Price is the Director of Strength & Performance Science for the Los Angeles Kings and was formerly the lead strength and conditioning coach for Alpine Canada.
Brianne Brown: Brianne Brown, Head of Women's Basketball Strength & Conditioning at the University of Miami, has over seven years of experience, including positions at the University of Pittsburgh and Racing Louisville FC, and holds a Master's in Exercise Science and Human Performance from Utah State University.
David Lawrence: David Lawrence is a renowned strength coach who has trained NFL athletes, including six Super Bowl champions, to enhance their body composition, speed, and performance, with his work featured in Sports Illustrated, ESPN, and The Athletic.
Dr. Jordan Shallow: Dr. Jordan Shallow is a strength coach, powerlifter, chiropractor, and founder of Pre-Script.com, specializing in innovative strategies to improve human performance for elite athletes and corporations.
Mark Fitzgerald: Mark Fitzgerald has 15 years of experience working with athletes at all levels, including CWENCH's very own Gavin McKenna. Mark founded Elite Training Systems in Ontario, served as Head of Performance for the Anaheim Ducks, and is the lead training advisor for Under Armour Canada, while consulting for various health and performance organizations.
Dan Noble: Dan Noble is the Director of Hockey at Upper Canada College, the Director of Performance for the Oshawa Generals, owns and runs Noble Sport & Performance, and is a Family Coach and Speaker.
Alan Bishop: Alan Bishop, Director of Sports Performance for the University of Houston Men's Basketball program, is a highly regarded coach known for his pragmatic approach and leadership in strength and conditioning, driving impressive physical development in his teams year after year. Alan is considered a godfather in NCAA basketball, placing many of his disciples into programs across the country.
Doug Crashley: Doug Crashley trains world class athletes through Crash Conditioning, a premier training destination for elite hockey players that offers individualized training programs and intuitive coaching based on sports science research.
Dr. Sachin Patel: Dr. Sachin Patel, a functional medicine coach, international speaker, and author, founded The Living Proof Institute to transform healthcare through patient-centered practices and lifestyle changes, while mentoring practitioners globally to provide affordable, inspired care.
Derrell Levy: Derrell Levy trains world class athletes through In-Tech High Performance Training. With over 12 years of on-ice coaching experience, Derrell has developed strength and conditioning programs for elite basketball and hockey teams, as well as NBA, NHL, OHL, and AHL athletes.
Sam Davis: Sam Davis is a Fitness Business Consultant, Women's Health Advisor, and the Founder of Powerfully Fit Training. Sam if a former NCAA athlete, and provides coaching for other well-known fitness influencers and helps them develop their own programs.
Ryan Vigneau: Ryan Vigneau is an Athlete Development Coach and runs RVX Performance, an elite training facility that works with NHL athletes in Edmonton.
Cizzle Brands' Chief Performance Officer Andy O'Brien is also one of the Company's SMEs. Andy was nicknamed "The Muscle Whisperer" by Sportsnet in 2015, highlighting his work as a trainer to NHL superstar Sidney Crosby, MVP and CWENCH's very own Nathan MacKinnon, Olympic medallist figure skater Patrick Chan, women's hockey legend Hayley Wickenheiser, and Olympic swimmer Dara Torres. Andy has also held coaching and consultancy roles for the Pittsburgh Penguins and Florida Panthers.
Additionally, Don Saladino will be an ambassador specifically for CWENCH Hydration™. Earlier this week, Cizzle Brands announced that it was engaging Mr. Saladino as an advisor, which will enable the Company to leverage his insights, expertise, and professional network as a well-known personal trainer to Hollywood's A-List, professional athletes, and award-winning musicians. Mr. Saladino has a high-profile social media presence, with over 432,000 followers on his Instagram channel .
Cizzle Brands Chairman and Chief Executive Officer, John Celenza, commented, "In an era when product competition is fierce, we believe that the best way to stand out is by working with the world's most experienced subject matter experts to develop products of unparalleled quality and performance, like we have with CWENCH Hydration™ and Spoken Nutrition. There are very few companies out there that have as much knowledge, reach, and fire power as the team of SMEs that are behind Cizzle Brands' products. Not only are they helping us to develop our amazing lineup of products, they are also our loudest evangelists. Furthermore, anyone in the sports nutrition industry will understand that when Cizzle Brands' SMEs speak, people who matter pay attention, which can drive accelerated growth for the Company."
About Cizzle Brands Corporation
Cizzle Brands Corporation is elevating the game in health and wellness. Through extensive collaboration and testing with leading athletes and trainers across several elite sports, Cizzle Brands has launched two leading product lines in the sports nutrition category: (i) CWENCH Hydration, a better-for-you sports drink that is now carried in over 1,200 stores in Canada, the United States, and Europe; and (ii) Spoken Nutrition, a premium brand of athlete-grade nutraceuticals that carry the prestigious NSF Certified for Sport® qualification. All Cizzle Brands products are designed to help people achieve their best in both competitive sports and in living a healthy, vibrant, active lifestyle.
For more information about Cizzle Brands, please visit: https://www.cizzlebrands.com/
Notice Regarding Images and Links: This press release may contain images and/or links to outside web pages, which could play an important role in providing the full context of the news update being conveyed through this press release. Some news aggregation services may remove these images and/or links at their discretion. Therefore, readers are encouraged to access SEDAR+ or the News section of the Cizzle Brands Corporation website to view this press release containing all images and/or links as originally published.
On behalf of the Board of Directors of the Company,
"John Celenza"
John Celenza, Chairman and Chief Executive Officer
CAUTIONARY NOTE REGARDING FORWARD-LOOKING INFORMATION
This news release contains "forward-looking information" which may include, but is not limited to, information with respect to the activities, events or developments that the Company expects or anticipates will or may occur in the future, such as, but not limited to: new products of the Company and potential sales and distribution opportunities. Such forward-looking information is often, but not always, identified by the use of words and phrases such as "plans", "expects", "is expected", "budget", "scheduled", "estimates", "forecasts", "intends", "anticipates", or "believes" or variations (including negative variations) of such words and phrases, or state that certain actions, events or results "may", "could", "would", "might" or "will" be taken, occur or be achieved. Various assumptions or factors are typically applied in drawing conclusions or making the forecasts or projections set out in forward-looking information. Those assumptions and factors are based on information currently available to the Company.
Forward looking information involves known and unknown risks, uncertainties and other risk factors which may cause the actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking information. Such risks include risks related to increased competition and current global financial conditions, access and supply risks, reliance on key personnel, operational risks, regulatory risks, financing, capitalization and liquidity risks. Although the Company has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking information, there may be other factors that cause results not to be as anticipated, estimated or intended. There can be no assurance that such information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking information. The Company undertakes no obligation, except as otherwise required by law, to update these forward-looking statements if management's beliefs, estimates or opinions, or other factors change.
View source version on businesswire.com: https://www.businesswire.com/news/home/20250123730912/en/
For further information, please contact:
Setti Coscarella
Head of Corporate Development
investors@cizzlebrands.com
1-844-588-2088
News Provided by Business Wire via QuoteMedia
Don Saladino, Personal Trainer to Hollywood's A-List, Joins Cizzle Brands as an Advisor
Hollywood actors, professional athletes, and award-winning musicians alike have all relied on Don Saladino, coach and trainer of over 20 years, to reach their full potential in physical fitness. As an advisor to Cizzle Brands, Mr. Saladino will provide his insights, expertise, and access to his vast professional network for the commercialization and promotion of Cizzle Brands' product lines at a global scale.
Cizzle Brands Corporation (Cboe Canada: CZZL) ( the "Company or "Cizzle Brands") , is pleased to announce that Don Saladino, a renowned coach and fitness expert to many A-List celebrities, professional athletes, and award-winning musicians has been engaged as an advisor to Cizzle Brands to help guide the Company's commercialization journey in the health and wellness space. Under his agreement with Cizzle Brands, Mr. Saladino will provide sales, marketing, and promotional support for Cizzle Brands' offerings, including through his TikTok (165k followers) and Instagram (432k followers) social media channels.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250121943080/en/

Don Saladino's one-minute Intro Reel video can be viewed on YouTube: https://www.youtube.com/watch?v=5L57AYEjZF4 (Photo: Business Wire)
Mr. Saladino has developed a reputation for training several A-List Hollywood stars, including Ryan Reynolds, Blake Lively, Anne Hathaway, John Krasinski, Emily Blunt, Liev Schreiber, Hugh Jackman and Joanna Gaines. In 2020, Mr. Saladino pivoted from running a brick-and-mortar gym in New York City to operating a global online fitness business which includes workout programs and challenges, an e-commerce portal for supplements, the Don Saladino App (available on the Apple App Store and Google Play), and yearly fitness retreats. Mr. Saladino has an extensive network of celebrity personalities to whom he will be supplying Cizzle Brands' products throughout the course of their training programs.
Additionally, Mr. Saladino has received extensive media coverage. Magazines such as Men's Health , Women's Health , and Muscle & Fitness have cited Mr. Saladino as a fitness expert. Muscle & Fitness has also featured Mr. Saladino on its print magazine cover in March 2018, October 2021, and November 2023. Other publications have featured Mr. Saladino including People , US Weekly , Cosmo , and Shape . Additionally, Mr. Saladino has done live fitness demonstrations on The Golf Channel , The Today Show , Good Morning America , Page Six TV , People NOW , E News , Fox News , and WebMD .
More information about Don Saladino can be found on his website at the following link: https://donsaladino.com/
Cizzle Brands Chairman and Chief Executive Officer, John Celenza, commented, "We are keen to be working with Don, as he is one of the most recognized names in the fitness world with a highly engaged following, a well-earned reputation for generating results, and a broad network of highly influential executives. Cizzle Brands is only getting started with building out its presence in the world of health and wellness. With Don's knowledge of what the world's most elite athletes, entrepreneurs, and actors are demanding, we expect he will prove to be extraordinarily valuable to us as an advisor."
Regarding his appointment as an advisor to Cizzle Brands, Don Saladino commented, "In today's marketplace, very few companies truly have what it takes to formulate and produce athlete-grade products for training, nutrition, hydration, and overall wellness while also being appropriate for active people of all ages. The proven team behind Cizzle Brands has already demonstrated their ability to meet this standard with the recent successful launch of CWENCH Hydration™ which has already sold more than one million ready-to-drink units in less than a year on the market, with even more exciting offerings set to hit the market soon. As someone who personally incorporates Cizzle Brands' products into nutrition regimes for myself, my wife, and our two children, I am honoured to be part of the Cizzle Brands team, and there are exciting times to be had for all of us in 2025!"
Cizzle Brands also announced the issuance of 455,645 common shares (the "Settlement Shares") of the Company at a deemed price of $0.31 in settlement of $141,250 in debt. The Settlement Shares were issued to a provider who elected to receive part of their service fee in shares as opposed to cash. The Settlement Shares will be subject to a statutory hold period expiring four months and one day after the date of issuance pursuant to National Instrument 45-102 – Resale of Securities .
Celenza added: "I've always sought to have our key partners invested in our success, so I was pleased when one of our key professional advisers opted to receive part of their fee in equity. To me, it is one of the highest endorsements we've received to date."
About Cizzle Brands Corporation
Cizzle Brands Corporation is elevating the game in health and wellness. Through extensive collaboration and testing with leading athletes and trainers across several elite sports, Cizzle Brands has launched two leading product lines in the sports nutrition category: (i) CWENCH Hydration, a better-for-you sports drink that is now carried in over 1,200 stores in Canada, the United States, and Europe; and (ii) Spoken Nutrition, a premium brand of athlete-grade nutraceuticals that carry the prestigious NSF Certified for Sport® qualification. All Cizzle Brands products are designed to help people achieve their best in both competitive sports and in living a healthy, vibrant, active lifestyle.
For more information about Cizzle Brands, please visit: https://www.cizzlebrands.com/
Notice Regarding Images and Links: This press release may contain images and/or links to outside web pages, which could play an important role in providing the full context of the news update being conveyed through this press release. Some news aggregation services may remove these images and/or links at their discretion. Therefore, readers are encouraged to access SEDAR+ or the News section of the Cizzle Brands Corporation website to view this press release containing all images and/or links as originally published.
On behalf of the Board of Directors of the Company,
"John Celenza"
John Celenza, Chairman and Chief Executive Officer
CAUTIONARY NOTE REGARDING FORWARD-LOOKING INFORMATION
This news release contains "forward-looking information" which may include, but is not limited to, information with respect to the activities, events or developments that the Company expects or anticipates will or may occur in the future, such as, but not limited to: new products of the Company and potential sales and distribution opportunities; the role of Mr. Saladino with Cizzle Brands; the supply of Cizzle Brands' products through Mr. Saladino's training programs; the building of Cizzle Brands' presence in the world of health and wellness; and the value of Mr. Saladino as an advisor to Cizzle Brands. Such forward-looking information is often, but not always, identified by the use of words and phrases such as "plans", "expects", "is expected", "budget", "scheduled", "estimates", "forecasts", "intends", "anticipates", or "believes" or variations (including negative variations) of such words and phrases, or state that certain actions, events or results "may", "could", "would", "might" or "will" be taken, occur or be achieved. Various assumptions or factors are typically applied in drawing conclusions or making the forecasts or projections set out in forward-looking information. Those assumptions and factors are based on information currently available to the Company.
Forward looking information involves known and unknown risks, uncertainties and other risk factors which may cause the actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking information. Such risks include risks related to increased competition and current global financial conditions, access and supply risks, reliance on key personnel, operational risks, regulatory risks, financing, capitalization and liquidity risks. Although the Company has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking information, there may be other factors that cause results not to be as anticipated, estimated or intended. There can be no assurance that such information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking information. The Company undertakes no obligation, except as otherwise required by law, to update these forward-looking statements if management's beliefs, estimates or opinions, or other factors change.
View source version on businesswire.com: https://www.businesswire.com/news/home/20250121943080/en/
For further information, please contact:
Setti Coscarella
Head of Corporate Development
investors@cizzlebrands.com
1-844-588-2088
News Provided by Business Wire via QuoteMedia
Cizzle Brands Corporation Teams up with Hockey Influencer, Coach Chippy, to launch Tropical Flow, a Special Edition Coach Chippy Inspired Flavour of CWENCH Hydration
With a combined social media following of more than one million users, Coach Chippy is a leading influencer in youth hockey. Through his Tropical Flow flavour of CWENCH Hydration, which will be available for purchase at Pro Hockey Life, Source for Sports, Sports Excellence and other leading retailers, Coach Chippy will be creating greater visibility for CWENCH Hydration in a key demographic for the brand.
Cizzle Brands Corporation (Cboe Canada: CZZL) ( the "Company or "Cizzle Brands") , is pleased to announce that it has teamed up with famed Canadian hockey influencer Coach Chippy to launch Tropical Flow , a special edition Coach Chippy-inspired flavour of CWENCH Hydration. Tropical Flow , which will be available in ready-to-drink and hydration mix formats, is CWENCH Hydration's fifth flavour option, along with Rainbow Swirl, Blue Raspberry, Cherry Lime and Berry Crush.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250116330910/en/

Canadian hockey influencer Coach Chippy has teamed up with Cizzle Brands to launch Tropical Flow, a new flavour of CWENCH Hydration™. Through his social media channels and major presence within the Canadian hockey sphere, the Company expects to cultivate valuable awareness for the CWENCH brand. (Photo: Business Wire)
The launch of Tropical Flow further strengthens the market position of CWENCH Hydration™ in the sports nutrition market. In Cizzle Brands' most recent quarterly financial results, the Company reported CAD $2.8 million in revenue from sales of CWENCH Hydration™ beverages and mixes, with CAD $1.75 million in gross profit for a 62.5% gross margin. Since its launch in late May of 2024, more than one million ready-to-drink ("RTD") units of CWENCH Hydration™ have been sold.
Under the agreement with Coach Chippy, Cizzle Brands will release a special-edition tropical fruit flavour of CWENCH Hydration™ featuring images of Coach Chippy, as well as his Style & Flow tagline (pictured below). At launch, Tropical Flow will be available for purchase at Pro Hockey Life, Source for Sports, Sports Excellence, Canlan Ice Sports and Buckingham Sports Group with additional retailers expected to offer it soon.
Coach Chippy will be a key driver in creating awareness for CWENCH Hydration and Tropical Flow through his social media profiles, which include:
TikTok: @coachchippyy (736,000 followers)
Instagram: @coach.chippy (450,000 followers)
YouTube: @coachchippy (111,000 followers)
More information about Coach Chippy can be found on his website at the following link: https://coachchippy.ca/en-cad/
Following its launch at the end of May 2024, CWENCH Hydration™ has established a robust brand profile among professional athletes and fans of all ages. As detailed in Cizzle Brands' Market Introduction press release , NHL players including Nathan MacKinnon and Cole Caufield have endorsed CWENCH Hydration™ as well as NBA All-Star Andrew Wiggins, Canadian Olympian Adriana Leon and up-and-coming hockey stars Gavin McKenna, Chloe Primerano and Jade Iginla. Additionally, CWENCH Hydration™ is the named sponsor of a four-rink hockey arena in Toronto known as CWENCH Centre - a Canlan Sports Community as well as a sponsor of over 500 youth hockey teams, which has the CWENCH brand displayed on the hockey gear of more than 12,000 youth hockey players across North America.
Cizzle Brands Chairman and Chief Executive Officer, John Celenza, commented, "In many ways, Coach Chippy represents so much of what is great about youth hockey - passion, commitment and a great sense of joy. His message resonates with so many kids. As a dad myself, I hear about Coach Chippy all the time and know how much clout he has with one of our key demographics for CWENCH Hydration™. Chippy has been a part of the Cizzle Brands story since the early days of the Company, and we are thrilled to be deepening our partnership with him to further strengthen the profile of CWENCH Hydration™ in hockey communities across North America."
Coach Chippy added, "I've had a bunch of companies hit me up about product partnerships, but teaming up with the crew at Cizzle Brands was a no-brainer. When you're dialed in on being your best, CWENCH Hydration™ is the real deal. It's all-natural, sugar-free, and loaded with 6+ electrolytes. The product being healthy was a big deal for me—it's one of the main reasons I decided to put my name (and face) behind it. Staying hydrated the smart way is a huge part of the whole Style and Flow vibe. I'm really excited to bring Tropical Flow to the market."
About Cizzle Brands Corporation
Cizzle Brands Corporation is elevating the game in health and wellness. Through extensive collaboration and testing with leading athletes and trainers across several elite sports, Cizzle Brands has launched two leading product lines in the sports nutrition category: (i) CWENCH Hydration, a better-for-you sports drink that is now carried in over 1,200 stores in Canada, the United States, and Europe; and (ii) Spoken Nutrition, a premium brand of athlete-grade nutraceuticals that carry the prestigious NSF Certified for Sport® qualification. All Cizzle Brands products are designed to help people achieve their best in both competitive sports and in living a healthy, vibrant, active lifestyle.
For more information about Cizzle Brands, please visit: https://www.cizzlebrands.com/
For more information about CWENCH, please visit: https://cwenchhydration.com/
For more information about Spoken Nutrition, please visit: https://spokennutrition.com/
On behalf of the Board of Directors of the Company,
"John Celenza"
John Celenza, Chief Executive Officer
CAUTIONARY NOTE REGARDING FORWARD-LOOKING INFORMATION
This news release contains "forward-looking information" which may include, but is not limited to, information with respect to the activities, events or developments that the Company expects or anticipates will or may occur in the future, such as, but not limited to: new products of the Company and potential sales and distribution opportunities. Such forward-looking information is often, but not always, identified by the use of words and phrases such as "plans", "expects", "is expected", "budget", "scheduled", "estimates", "forecasts", "intends", "anticipates", or "believes" or variations (including negative variations) of such words and phrases, or state that certain actions, events or results "may", "could", "would", "might" or "will" be taken, occur or be achieved. Various assumptions or factors are typically applied in drawing conclusions or making the forecasts or projections set out in forward-looking information. Those assumptions and factors are based on information currently available to the Company.
Forward looking information involves known and unknown risks, uncertainties and other risk factors which may cause the actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking information. Such risks include risks related to increased competition and current global financial conditions, access and supply risks, reliance on key personnel, operational risks, regulatory risks, financing, capitalization and liquidity risks. Although the Company has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking information, there may be other factors that cause results not to be as anticipated, estimated or intended. There can be no assurance that such information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking information. The Company undertakes no obligation, except as otherwise required by law, to update these forward-looking statements if management's beliefs, estimates or opinions, or other factors change.
View source version on businesswire.com: https://www.businesswire.com/news/home/20250116330910/en/
For further information, please contact:
Setti Coscarella
Head of Corporate Development
investors@cizzlebrands.com
1-844-588-2088
News Provided by Business Wire via QuoteMedia
Biotech Market Forecast: Top Trends for Biotech in 2025
The biotech sector in 2025 presents a landscape brimming with both opportunities and challenges.
The industry is being shaped by a confluence of factors, all of which are driving exciting innovations in healthcare.
Drawing from insights gained at the JP Morgan Healthcare Conference (JPMHC), held in San Francisco from January 13 to 16, the Investing News Network examines the key trends taking shape in biotech in 2025.
M&A and the future of therapy
Following a period of market stagnation, Evaluate's 2025 Market Preview suggests cautious optimism for the biotech sector in 2025. Industry experts anticipate increased mergers and acquisitions (M&A) and improved access to capital fueled in part by a looming US$300 billion patent cliff.
Companies facing steep revenue losses will be seeking to refill their pipelines, creating a ripe environment for “the biotech innovation engine” as noted in a market report authored by Dr. Arda Ural, EY Americas Life Sciences sector leader, at the end of December. Promising biotech companies could become attractive acquisition targets.
Acquisitions announced this week at JPMHC underscore this trend, with several significant deals announced. The day before the conference, Gilead (NASDAQ:GILD) signaled its intent with a US$1.7 billion investment in Leo Pharma's preclinical inflammation drugs.
The first day of JPMHC saw even more action. Johnson & Johnson (J&J) (NYSE:JNJ) made one of the largest biotech acquisitions in recent memory when it announced it would acquire Intra-Cellular Therapies for US$14.6 billion. Intra-Cellular Therapies is the maker of Caplyta, an atypical antipsychotic approved to treat schizophrenia and bipolar depression. This acquisition expands J&J's presence in the neuroscience market.
GSK (NYSE:GSK) also announced a strategic acquisition at JPMHC, striking a US$1.15 billion buyout deal for IRDx, a company developing non-invasive diagnostics for gastrointestinal (GI) cancers.
Vera Therapeutics (NASDAQ:VERA) later announced a licensing agreement with Stanford University for VT-109, a fusion protein designed to treat B cell diseases by targeting two proteins involved in overactive immune cell activity.
Inflammation and immunology (I&I) were indeed two prominent areas of interest at the conference. AbbVie's (NYSE:ABBV) CEO, Rob Michael, highlighted the company's strong performance in this area, driven by the success of Skyrizi (risankizumab) and Rinvoq (upadacitinib), which he said have effectively offset the revenue decline from Humira's patent expiration during a discussion at the conference. The company’s acquisition of Nimble Therapeutics for its preclinical IL-23 inhibitor highlights the ongoing search for innovative treatments for inflammatory diseases
Meanwhile, Kyverna Therapeutics (NASDAQ:KYTX) presented its ambitious goal of developing the first chimeric antigen receptor T-cell (CAR-T) therapy for autoimmune diseases.
Insight released by JPM senior analyst of large-cap biotechnology Jess Fye ahead of the conference also cited oncology as another therapeutic area of focus. That was evidenced by Eli Lilly's (NYSE:LLY) US$2.5 billion purchase of Scorpion Therapeutics on January 13, positioning them as a potential leader in the development of a new class of cancer drugs with their acquisition of STX-678, an experimental drug undergoing clinical trials.
This focus on oncology was further underscored by several partnerships and developments announced before and during the conference, including Boehringer Ingelheim licensing Lonza's antibody-drug conjugate (ADC) technology, Chugai (OTCPINK:CHGCF) and Araris's research collaboration to develop ADC treatments and Ginkgo Bioworks (NYSE:DNA) collaborating with Astellas (OTCPINK:ALPMF) to optimize next-generation cancer treatments. GSK highlighted its upcoming ADC Blenrep, and Novartis (NYSE:NVS) emphasized the potential of its breast cancer drug Kisqali.
Beyond oncology and I&I, the conference highlighted the continued interest in gene and cell therapy, with the US Food & Drug Administration (FDA) Center for Biological Evaluation and Research director Peter Marks saying his agency is aiming to accelerate approvals of gene therapies like CRISPR medicine Casgevy, Pfizer’s (NYSE:PFE) Beqvez and PTC Therapeutics (NASDAQ:PTC) Kebilidi. Denali Therapeutics (NASDAQ:DNLI) also shared an update on its leading asset to treat Hunter syndrome, DNL310 (tividenofusp alfa), announcing its intent to file for regulatory approval in 2025.
The company also said it expects to have one or two new drugs ready to bring to the clinic every year for the next three years thanks to its Transport Vehicle platform, a molecule capable of passing the blood-brain barrier.
Neurology also garnered attention. Apart from J&J’s acquisition, Bayer (OTCPINK:BAYRY) announced that it was moving onto Phase II trials of an allogeneic cell therapy to treat Parkinson’s disease. Earlier in Q1 2025, Biogen's (NASDAQ:BIIB) pursuit of Sage Therapeutics (NASDAQ:SAGE) and their jointly developed mood-stabilizing medicine Zurzuvae caused Sage’s stock price to surge more than 38 percent over the weekend.
Furthermore, Vertex Pharmaceuticals (NASDAQ:VRTX) awaits an FDA decision on its novel non-opioid pain treatment, suzetrigine, which is expected by January 30.
While M&A is on the rise, companies in biopharma have signaled a cautious approach to
the funding environment that could still be challenging for early-stage companies. Roche (OTCQX:RHHBF) recently decided to pull about 30 percent of its pipeline and, at JPMHC, said it has US$10 billion for M&A this year but will only spend it on "transformative assets" complementary to its portfolio or that "change the game" in important diseases.
AbbVie CEO Rob Michaels shared this sentiment in Oppenheimer’s 2024-25 Biopharma M&A and Strategic Collaboration Insight report. “Our main focus is our five key growth areas...immunology, oncology, neuroscience, aesthetics and eye care...So far this year, we’ve executed 15 deals along those lines, really focus(ing) more on early‐stage opportunities to drive growth in the next decade. So, that’s our primary focus.”
Impact of AI on biotech R&D
When AlphaFold, a groundbreaking artificial intelligence (AI) system with revolutionary protein structure prediction capabilities developed by Google’s (NASDAQ:GOOGL) DeepMind, was awarded the prestigious Nobel Prize in Chemistry in October 2024, the potential for AI to play an increasingly critical role in drug discovery and development became a more prominent topic of conversation.
AI applications like AlphaFold could reduce development costs, lessening biotech's reliance on partnerships or acquisitions from Big Pharma to secure funding. This would allow smaller companies to better protect their intellectual property and introduce more innovative drugs.
The FDA's release of draft guidance on AI in drug development further underscores the growing importance of AI in the biotech sector, signaling a shift towards greater acceptance and adoption of AI-based tools in the regulatory process.
Biotech under Trump: A new regulatory era?
Policy can either promote or hinder growth in a sector by affecting factors such as market access, the cost of compliance and funding for research. Regulatory changes and leadership appointments under President Trump have the potential to significantly impact the biotech industry. As Daphne Zohar, CEO of Seaport Therapeutics and former head of PureTech Health (NASDAQ:PRTC), noted in an email to Biopharma Dive, a change in FTC leadership could have a positive effect.
Current Federal Trade Commission (FTC) chairwoman Lina Khan's policies have been unfavorable to the healthcare industry and included heavy scrutiny of M&As. Trump’s picks – Andrew Ferguson as FTC chair and Mark Meador as a commissioner – are seen as likely to be less restrictive in their approach to dealmaking.
However, uncertainty around the confirmation of key health department appointments and an evolving tariff situation may contribute to market volatility in the short term. “Uncertainty always creates volatility, and volatility is not great for the public markets,” said Rebecca Stevenson, according to BioPharmaDive’s coverage of JPMHC. “Ultimately the dust needs to settle before we see generalist [investors] back in. Is that happening in the next six months? Probably not.”
On the other hand, it's important to consider that any potential policy shifts may take time to emerge, as the confirmation process for President-elect Trump's cabinet picks could take until mid-2025, as noted by the Evaluate authors.
Trump’s choice for FDA Commission, Johns Hopkins University pancreatic surgeon Dr. Marcus Makary, was well-received by the industry, who sees him as a more conventional pick than Trump’s choice to lead the Department of Health and Human Services, Robert F. Kennedy Jr.
Kennedy has stated that the high prevalence of chronic diseases in the US necessitates significant changes to the healthcare system. Financial disclosures from Stat+ indicate a vested interest in biotech investments, and his oversight could also breathe new life into stem cell research. In the aforementioned post, Kennedy wrote that he would support unconventional medical fields, including stem cell injections and nutraceuticals. In a post to X after his October nomination, Kennedy issued a warning: “FDA’s war on public health is about to end.”
Investor takeaway
The biotech sector in 2025 is at a crossroads, presenting a dynamic landscape of opportunities and challenges. As the sector navigates these complexities, collaboration between academia, industry and government will be crucial to unlocking its full potential and addressing the pressing healthcare challenges of the 21st century. Investors will need to closely monitor both clinical data and regulatory developments.
Don’t forget to follow @INN_LifeScience for real-time updates!
Securities Disclosure: I, Meagen Seatter, hold no direct investment interest in any company mentioned in this article.
Editorial Disclosure: Radiopharm Theranostics and Sirona Biochem are clients of the Investing News Network. This article is not paid-for content.
FDA APPROVES LUMAKRAS® IN COMBINATION WITH VECTIBIX® FOR CHEMOREFRACTORY KRAS G12C-MUTATED METASTATIC COLORECTAL CANCER
Pivotal Study Demonstrated the Combination More Than Doubled Progression-Free Survival Compared to Investigated SOC
Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved LUMAKRAS ® (sotorasib) in combination with Vectibix ® (panitumumab) for the treatment of adult patients with KRAS G12C-mutated metastatic colorectal cancer (mCRC), as determined by an FDA-approved test, who have received prior fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy. Approval is based on the pivotal Phase 3 CodeBreaK 300 study, which demonstrated that LUMAKRAS plus Vectibix is the first and only targeted treatment combination for chemorefractory KRAS G12C-mutated mCRC to show superior progression-free survival (PFS) compared to the investigated standard-of-care (SOC). 1*
"Colorectal cancer is the third leading cause of cancer-related deaths in the United States , and fewer than one in five people diagnosed with metastatic disease survive beyond five years after diagnosis," said Jay Bradner , M.D., executive vice president of Research and Development at Amgen. 2 "LUMAKRAS plus Vectibix offers a targeted, biomarker-driven combination therapy that helps delay disease progression more effectively than the investigated standard of care. This new option validates our combination approach to improve outcomes for patients living with advanced KRAS G12C-mutated metastatic colorectal cancer."
The CodeBreaK 300 clinical trial compared LUMAKRAS at two different doses (960 mg daily or 240 mg daily) in combination with Vectibix to the investigator's choice of SOC (trifluridine and tipiracil or regorafenib) in patients with chemorefractory KRAS G12C-mutated mCRC. Study results demonstrated that LUMAKRAS 960 mg daily plus Vectibix (n=53) showed an improved median PFS of 5.6 months (4.2, 6.3) compared to 2 months (1.9, 3.9) on investigator's choice of care (n=54), with a hazard ratio (HR) of 0.48 (95% Confidence Interval [CI]: 0.3, 0.78) and a p -value of 0.005. The study demonstrated an improved overall response rate (ORR) of 26% (95% CI: 15, 40) compared to 0% with investigator's choice (95% CI: 0, 7). The study was not statistically powered for overall survival (OS). The median overall survival (mOS) for patients treated with LUMAKRAS plus Vectibix was not reached (NR) (8.6, NR), and mOS for patients treated with investigator's choice was 10.3 months (7, NR), with a HR of 0.7 (95% CI: 0.41, 1.18); the final analysis of OS was not statistically significant. Safety profiles were consistent with those historically observed for LUMAKRAS and Vectibix. The most common adverse reactions (≥20%) are rash (87%), dry skin (28%), diarrhea (28%), stomatitis (26%), fatigue (21%) and musculoskeletal pain (21%). PFS of LUMAKRAS 240 mg daily plus Vectibix (n=53) compared to investigator's choice was not statistically significant.
The KRAS G12C mutation is present in approximately 3-5% of colorectal cancers as determined by an FDA-approved biomarker test. 3-5 This emphasizes the important role of comprehensive biomarker testing in mCRC. By detecting an actionable mutation, eligible patients are now able to receive a corresponding targeted therapy that may lead to improved responses.
"In metastatic colorectal cancer, KRAS mutations are historically associated with worse mortality rates and inferior outcomes compared to non-mutated tumors, and standard treatment options have shown minimal benefit," said Marwan G. Fakih , M.D., primary study investigator and co-director of the Gastrointestinal Cancer Program, City of Hope. 3-6 "Designed for dual blockade of KRAS G12C and EGFR pathways, the combination of sotorasib plus panitumumab provides a needed new treatment option to better overcome cancer's escape mechanisms. The CodeBreaK 300 study showed superior progression-free survival compared to the investigated standard of care and represents a clinically meaningful benefit for patients with KRAS G12C-mutated metastatic colorectal cancer."
"There is an immense need for continued innovation and precision medicine to help address metastatic colorectal cancer," said Michael Sapienza , Chief Executive Officer of the Colorectal Cancer Alliance. "This new combination approach is an important breakthrough for patients with KRAS G12C-mutated metastatic colorectal cancer, offering a new beneficial treatment option for patients living with this devastating and challenging disease."
* Investigator's choice for SOC included trifluridine/tipiracil or regorafenib.
About CodeBreaK 300
The CodeBreaK 300 trial enrolled 160 participants and compared LUMAKRAS ® (sotorasib) at doses of 960 mg and 240 mg in combination with Vectibix ® (panitumumab) to investigator's choice of standard of care (trifluridine/tipiracil or regorafenib) in patients with chemorefractory KRAS G12C-mutated metastatic colorectal cancer (mCRC). The study met its primary endpoint showing improved progression-free survival (PFS), and the key secondary endpoints of overall survival (OS) and overall response rate (ORR) also favored the combination.
About mCRC and the KRAS G12C Mutation
Colorectal cancer (CRC) is the second leading cause of cancer deaths worldwide, comprising 11% of all cancer diagnoses. 7 It is also the third most commonly diagnosed cancer globally. 8
Patients with previously treated mCRC need more effective treatment options. For patients in the third-line setting, standard therapies yield median OS times of less than one year, and patients' response rates are less than 10%. 9
KRAS mutations are among the most common genetic alterations in CRC, with the KRAS G12C mutation present in approximately 3-5% of CRC cases as determined by a U.S. Food and Drug Administration (FDA)-approved biomarker test. 3-5
About LUMAKRAS ® (sotorasib) in Combination with Vectibix ® (panitumumab)
In the U.S., LUMAKRAS is now approved in combination with Vectibix ® (panitumumab) for the treatment of adult patients with KRAS G12C-mutated mCRC, as determined by an FDA-approved test, who have received prior fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy. This targeted therapy combines LUMAKRAS, a KRAS G12C inhibitor, with Vectibix, a monoclonal anti-EGFR antibody. The recommended dose of LUMAKRAS is 960 mg daily, and the recommended dose of Vectibix is 6 mg/kg IV q2 weeks.
About LUMAKRAS ® /LUMYKRAS ® (sotorasib)
LUMAKRAS received accelerated approval from the FDA on May 28, 2021 . The FDA completed its review of Amgen's supplemental New Drug Application (sNDA) seeking full approval of LUMAKRAS on December 26, 2023 , which resulted in a complete response letter. In addition, the FDA concluded that the dose comparison postmarketing requirement (PMR) issued at the time of LUMAKRAS accelerated approval, to compare the safety and efficacy of LUMAKRAS 960 mg daily dose versus a lower daily dose, has been fulfilled. The company said LUMAKRAS at 960 mg once-daily will remain the dose for patients with KRAS G12C-mutated non-small cell lung cancer (NSCLC) under accelerated approval. The FDA also issued a new PMR for an additional confirmatory study to support full approval that will be completed no later than February 2028.
About Vectibix ® (panitumumab)
Vectibix is the first and only human monoclonal anti-EGFR antibody fully approved by the FDA for the treatment of mCRC. Vectibix was approved in the U.S. in September 2006 as a monotherapy for the treatment of patients with EGFR-expressing mCRC following disease progression after prior treatment with fluoropyrimidine-, oxaliplatin- and irinotecan-containing chemotherapy.
In May 2014, the FDA approved Vectibix for use in combination with FOLFOX as first-line treatment in patients with wild-type KRAS (exon 2) mCRC. With this approval, Vectibix became the first-and-only anti-EGFR biologic therapy indicated for use with FOLFOX, one of the most commonly used chemotherapy regimens, in first-line treatment of mCRC for patients with wild-type KRAS mCRC.
In June 2017, the FDA approved a refined indication for Vectibix for use in patients with wild-type RAS (defined as wild-type in both KRAS and NRAS as determined by an FDA-approved test for this use) mCRC, specifically as first-line therapy in combination with FOLFOX and as monotherapy following disease progression after prior treatment with fluoropyrimidine-, oxaliplatin- and irinotecan-containing chemotherapy.
LUMAKRAS ® (sotorasib) in Combination with Vectibix ® (panitumumab) U.S. Indication
Vectibix ® in combination with sotorasib, is indicated for the treatment of adult patients with KRAS G12C -mutated mCRC, as determined by an FDA-approved test, who have received prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.
LIMITATIONS OF USE
Vectibix ® is not indicated for the treatment of patients with RAS- mutant mCRC unless used in combination with sotorasib in KRAS G12C-mutated mCRC. Vectibix ® is not indicated for the treatment of patients with mCRC for whom RAS mutation status is unknown.
IMPORTANT SAFETY INFORMATION FOR LUMAKRAS ® (SOTORASIB)
Hepatotoxicity
- LUMAKRAS ® can cause hepatotoxicity and increased ALT or AST which may lead to drug-induced liver injury and hepatitis.
- In the pooled safety population of NSCLC patients who received single agent LUMAKRAS ® 960 mg hepatotoxicity occurred in 27% of patients, of which 16% were Grade ≥ 3. Among patients with hepatotoxicity who required dosage modifications, 64% required treatment with corticosteroids.
- In this pooled safety population of NSCLC patients who received single agent LUMAKRAS ® 960 mg, 17% of patients who received LUMAKRAS ® had increased alanine aminotransferase (ALT)/increased aspartate aminotransferase (AST); of which 9% were Grade ≥ 3. The median time to first onset of increased ALT/AST was 6.3 weeks (range: 0.4 to 42). Increased ALT/AST leading to dose interruption or reduction occurred in 9% of patients treated with LUMAKRAS ® . LUMAKRAS ® was permanently discontinued due to increased ALT/AST in 2.7% of patients. Drug-induced liver injury occurred in 1.6% (all grades) including 1.3% (Grade ≥ 3).
- In this pooled safety population of NSCLC patients who received single agent LUMAKRAS ® 960 mg, a total of 40% patients with recent (≤ 3 months) immunotherapy prior to starting LUMAKRAS ® had an event of hepatotoxicity. An event of hepatotoxicity was observed in 18% of patients who started LUMAKRAS ® more than 3 months after last dose of immunotherapy and in 17% of those who never received immunotherapy. Regardless of time from prior immunotherapy, 94% of hepatotoxicity events improved or resolved with dosage modification of LUMAKRAS ® , with or without corticosteroid treatment.
- Monitor liver function tests (ALT, AST, alkaline phosphatase and total bilirubin) prior to the start of LUMAKRAS ® , every 3 weeks for the first 3 months of treatment, then once a month or as clinically indicated, with more frequent testing in patients who develop transaminase and/or bilirubin elevations. Withhold, reduce the dose or permanently discontinue LUMAKRAS ® based on severity of the adverse reaction. Consider administering systemic corticosteroids for the management of hepatotoxicity.
Interstitial Lung Disease (ILD)/Pneumonitis
- LUMAKRAS ® can cause ILD/pneumonitis that can be fatal.
- In the pooled safety population of NSCLC patients who received single agent LUMAKRAS ® 960 mg ILD/pneumonitis occurred in 2.2% of patients, of which 1.1% were Grade ≥ 3, and 1 case was fatal. The median time to first onset for ILD/pneumonitis was 8.6 weeks (range: 2.1 to 36.7 weeks). LUMAKRAS ® was permanently discontinued due to ILD/pneumonitis in 1.3% of LUMAKRAS ® -treated patients. Monitor patients for new or worsening pulmonary symptoms indicative of ILD/pneumonitis (e.g., dyspnea, cough, fever). Immediately withhold LUMAKRAS ® in patients with suspected ILD/pneumonitis and permanently discontinue LUMAKRAS ® if no other potential causes of ILD/pneumonitis are identified.
Most Common Adverse Reactions
- The most common adverse reactions ≥ 20% were diarrhea, musculoskeletal pain, nausea, fatigue, hepatotoxicity, and cough.
Drug Interactions
- Advise patients to inform their healthcare provider of all concomitant medications, including prescription medicines, over-the-counter drugs, vitamins, dietary and herbal products.
- Inform patients to avoid proton pump inhibitors and H2 receptor antagonists while taking LUMAKRAS ® .
- If coadministration with an acid-reducing agent cannot be avoided, inform patients to take LUMAKRAS ® 4 hours before or 10 hours after a locally acting antacid.
Please see accompanying LUMAKRAS ® full Prescribing Information .
IMPORTANT SAFETY INFORMATION FOR VECTIBIX ® (PANITUMUMAB)
BOXED WARNING: DERMATOLOGIC TOXICITY
Dermatologic Toxicity: Dermatologic toxicities occurred in 90% of patients and were severe (NCI-CTC Grade 3 and higher) in 15% of patients receiving Vectibix ® monotherapy
- Vectibix ® can cause dermatologic toxicity, which may be severe. Clinical manifestations included, but were not limited to, acneiform dermatitis, pruritus, erythema, rash, skin exfoliation, paronychia, dry skin, and skin fissures.
- Among 229 patients who received Vectibix ® as monotherapy, dermatologic toxicity occurred in 90% including Grade 3 (15%). Among 585 patients who received Vectibix ® in combination with FOLFOX, dermatologic toxicity occurred in 96% including Grade 4 (1%) and Grade 3 (32%). In 126 patients receiving Vectibix ® in combination with sotorasib across clinical studies, dermatologic toxicities occurred in 94%, including Grade 3 (16%) of patients.
- Monitor patients who develop dermatologic or soft tissue toxicities while receiving Vectibix ® for the development of inflammatory or infectious sequelae. Life-threatening and fatal infectious complications including necrotizing fasciitis, abscesses, and sepsis have been observed in patients treated with Vectibix ® . Life-threatening and fatal bullous mucocutaneous disease with blisters, erosions, and skin sloughing has also been observed in patients treated with Vectibix ® . It could not be determined whether these mucocutaneous adverse reactions were directly related to EGFR inhibition or to idiosyncratic immune-related effects (eg, Stevens Johnson syndrome or toxic epidermal necrolysis). Withhold or discontinue Vectibix ® for dermatologic or soft tissue toxicity associated with severe or life-threatening inflammatory or infectious complications. Dose modifications for Vectibix ® concerning dermatologic toxicity are provided
- Vectibix ® monotherapy or in combination with oxaliplatin-based chemotherapy is not indicated for the treatment of patients with colorectal cancer that harbor somatic RAS mutations in exon 2 (codons 12 and 13), exon 3 (codons 59 and 61), and exon 4 (codons 117 and 146) of either KRAS or NRAS and hereafter is referred to as " RAS. "
- Retrospective subset analyses across several randomized clinical trials were conducted to investigate the role of RAS mutations on the clinical effects of anti-EGFR-directed monoclonal antibodies (panitumumab or cetuximab). Anti-EGFR antibodies in patients with tumors containing RAS mutations resulted in exposing those patients to anti-EGFR related adverse reactions without clinical benefit from these agents. Additionally, in Study 20050203, 272 patients with RAS -mutant mCRC tumors received Vectibix ® in combination with FOLFOX and 276 patients received FOLFOX alone. In an exploratory subgroup analysis , OS was shorter (HR = 1.21, 95% CI: 1.01-1.45) in patients with RAS -mutant mCRC who received Vectibix ® and FOLFOX versus FOLFOX alone.
- Vectibix ® can cause progressively decreasing serum magnesium levels leading to severe (Grade 3 or 4) hypomagnesemia. Among 229 patients who received Vectibix ® as monotherapy, hypomagnesemia occurred in 38% including Grade 4 (1.3%) and Grade 3 (2.6%). Among 585 patients who received Vectibix ® in combination with FOLFOX, hypomagnesemia occurred in 51% including Grade 4 (5%) and Grade 3 (6%). In 126 patients receiving Vectibix ® in combination with sotorasib across clinical studies, decreased magnesium occurred in 69%, including Grade 4 (2.4%) and Grade 3 (14%).
- Monitor patients for hypomagnesemia and hypocalcemia prior to initiating Vectibix ® treatment, periodically during Vectibix ® treatment, and for up to 8 weeks after the completion of treatment. Other electrolyte disturbances, including hypokalemia, have also been observed. Replete magnesium and other electrolytes as appropriate.
- In Study 20020408, 4% of patients experienced infusion reactions and 1% of patients experienced severe infusion reactions (NCI-CTC Grade 3-4). Infusion reactions, manifesting as fever, chills, dyspnea, bronchospasm, and hypotension, can occur following Vectibix ® administration. Fatal infusion reactions occurred in postmarketing experience. Terminate the infusion for severe infusion reactions.
- Severe diarrhea and dehydration, leading to acute renal failure and other complications, have been observed in patients treated with Vectibix ® . Among 229 patients who received Vectibix ® as monotherapy, acute renal failure occurred in 2% including Grades 3 or 4 (2%). Among 585 patients who received Vectibix ® in combination with FOLFOX, acute renal failure occurred in 2% including Grade 3 or 4 (2%). In 126 patients receiving Vectibix ® in combination with sotorasib across clinical studies, acute renal failure occurred in 3.2%, including Grade 3 (0.8%). Monitor patients for diarrhea and dehydration, provide supportive care (including anti-emetic or anti-diarrheal therapy) as needed, and withhold Vectibix ® if necessary.
- Fatal and nonfatal cases of interstitial lung disease (ILD) (1%) and pulmonary fibrosis have been observed in patients treated with Vectibix ® . Pulmonary fibrosis occurred in less than 1% (2/1467) of patients enrolled in clinical studies of Vectibix ® . Grade 1 ILD/pneumonitis occurred in 0.8% (1/126) of patients enrolled in clinical studies of Vectibix ® in combination with sotorasib. In the event of acute onset or worsening of pulmonary symptoms interrupt Vectibix ® therapy. Discontinue Vectibix ® therapy if ILD is confirmed.
- In patients with a history of interstitial pneumonitis or pulmonary fibrosis, or evidence of interstitial pneumonitis or pulmonary fibrosis, the benefits of therapy with Vectibix ® versus the risk of pulmonary complications must be carefully considered.
- Exposure to sunlight can exacerbate dermatologic toxicity. Advise patients to wear sunscreen and hats and limit sun exposure while receiving Vectibix ® .
- Serious cases of keratitis, ulcerative keratitis, and corneal perforation have occurred with Vectibix ® use. Among 585 patients who received Vectibix ® in combination with FOLFOX, keratitis occurred in 0.3%. In 126 patients receiving Vectibix ® in combination with sotorasib across clinical studies, keratitis occurred in 1.6%, ulcerative keratitis occurred in 0.8%, and vernal keratoconjunctivitis in 0.8% (all were Grade 1-2). Monitor for evidence of keratitis, ulcerative keratitis, or corneal perforation. Interrupt or discontinue Vectibix ® therapy for acute or worsening keratitis, ulcerative keratitis, or corneal perforation.
- In an interim analysis of an open-label, multicenter, randomized clinical trial in the first-line setting in patients with mCRC, the addition of Vectibix ® to the combination of bevacizumab and chemotherapy resulted in decreased OS and increased incidence of NCI-CTC Grade 3-5 (87% vs 72%) adverse reactions. NCI-CTC Grade 3-4 adverse reactions occurring at a higher rate in Vectibix ® -treated patients included rash/acneiform dermatitis (26% vs 1%), diarrhea (23% vs 12%), dehydration (16% vs 5%), primarily occurring in patients with diarrhea, hypokalemia (10% vs 4%), stomatitis/mucositis (4% vs ® -treated patients (7% vs 3%) and included fatal events in three ( ® -treated patients.
- As a result of the toxicities experienced, patients randomized to Vectibix ® , bevacizumab, and chemotherapy received a lower mean relative dose intensity of each chemotherapeutic agent (oxaliplatin, irinotecan, bolus 5-FU, and/or infusional 5-FU) over the first 24 weeks on study compared with those randomized to bevacizumab and chemotherapy.
- Based on data from animal studies and its mechanism of action, Vectibix ® can cause fetal harm when administered to a pregnant woman. When given during organogenesis, panitumumab administration resulted in embryolethality in cynomolgus monkeys at exposures approximately 1.25 to 5 times the recommended human dose. Advise pregnant women and females of reproductive potential of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment, and for at least 2 months after the last dose of Vectibix ® .
- In monotherapy, the most commonly reported adverse reactions (≥ 20%) in patients with Vectibix ® were skin rash with variable presentations, paronychia, fatigue, nausea, and diarrhea.
- The most commonly reported adverse reactions (≥ 20%) with Vectibix ® + FOLFOX were diarrhea, stomatitis, mucosal inflammation, asthenia, paronychia, anorexia, hypomagnesemia, hypokalemia, rash, acneiform dermatitis, pruritus, and dry skin. Serious adverse reactions (≥ 2% difference between treatment arms) were diarrhea and dehydration.
- The most common adverse reactions (≥ 20%) in patients receiving Vectibix ® in combination with sotorasib 960 mg were rash, dry skin, diarrhea, stomatitis, fatigue and musculoskeletal pain.
Please see full Prescribing Information , including Boxed WARNING.
About Amgen
Amgen discovers, develops, manufactures and delivers innovative medicines to help millions of patients in their fight against some of the world's toughest diseases. More than 40 years ago, Amgen helped to establish the biotechnology industry and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what's known today. Amgen is advancing a broad and deep pipeline that builds on its existing portfolio of medicines to treat cancer, heart disease, osteoporosis, inflammatory diseases and rare diseases.
In 2024, Amgen was named one of the "World's Most Innovative Companies" by Fast Company and one of "America's Best Large Employers" by Forbes, among other external recognitions . Amgen is one of the 30 companies that comprise the Dow Jones Industrial Average ® , and it is also part of the Nasdaq-100 Index ® , which includes the largest and most innovative non-financial companies listed on the Nasdaq Stock Market based on market capitalization.
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References
- Fakih M, et al. N Engl J Med. 2023;389(23): 2125- 2139.
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- Neumann J, et al. Pathol Res Pract . 2009;205(12):858-862.
- Jones RP, et al. Br J Cancer . 2017;116(7):923-929.
- Wiesweg M, et al. Oncogene . 2019;38(16):2953-2966.
- Fakih M, et al. The Oncologist . 2022;27(8):663–674.
- Rawla P, et al. Prz Gastroenterol . 2019;14(2):89-103.
- World Health Organization. 2022 Statistics. https://www.who.int/en/news-room/fact-sheets/detail/cancer . Accessed on August 20, 2024 .
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FDA APPROVES LUMAKRAS® IN COMBINATION WITH VECTIBIX® FOR CHEMOREFRACTORY KRAS G12C-MUTATED METASTATIC COLORECTAL CANCER
Pivotal Study Demonstrated the Combination More Than Doubled Progression-Free Survival Compared to Investigated SOC
Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved LUMAKRAS ® (sotorasib) in combination with Vectibix ® (panitumumab) for the treatment of adult patients with KRAS G12C-mutated metastatic colorectal cancer (mCRC), as determined by an FDA-approved test, who have received prior fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy. Approval is based on the pivotal Phase 3 CodeBreaK 300 study, which demonstrated that LUMAKRAS plus Vectibix is the first and only targeted treatment combination for chemorefractory KRAS G12C-mutated mCRC to show superior progression-free survival (PFS) compared to the investigated standard-of-care (SOC). 1*
"Colorectal cancer is the third leading cause of cancer-related deaths in the United States , and fewer than one in five people diagnosed with metastatic disease survive beyond five years after diagnosis," said Jay Bradner , M.D., executive vice president of Research and Development at Amgen. 2 "LUMAKRAS plus Vectibix offers a targeted, biomarker-driven combination therapy that helps delay disease progression more effectively than the investigated standard of care. This new option validates our combination approach to improve outcomes for patients living with advanced KRAS G12C-mutated metastatic colorectal cancer."
The CodeBreaK 300 clinical trial compared LUMAKRAS at two different doses (960 mg daily or 240 mg daily) in combination with Vectibix to the investigator's choice of SOC (trifluridine and tipiracil or regorafenib) in patients with chemorefractory KRAS G12C-mutated mCRC. Study results demonstrated that LUMAKRAS 960 mg daily plus Vectibix (n=53) showed an improved median PFS of 5.6 months (4.2, 6.3) compared to 2 months (1.9, 3.9) on investigator's choice of care (n=54), with a hazard ratio (HR) of 0.48 (95% Confidence Interval [CI]: 0.3, 0.78) and a p -value of 0.005. The study demonstrated an improved overall response rate (ORR) of 26% (95% CI: 15, 40) compared to 0% with investigator's choice (95% CI: 0, 7). The study was not statistically powered for overall survival (OS). The median overall survival (mOS) for patients treated with LUMAKRAS plus Vectibix was not reached (NR) (8.6, NR), and mOS for patients treated with investigator's choice was 10.3 months (7, NR), with a HR of 0.7 (95% CI: 0.41, 1.18); the final analysis of OS was not statistically significant. Safety profiles were consistent with those historically observed for LUMAKRAS and Vectibix. The most common adverse reactions (≥20%) are rash (87%), dry skin (28%), diarrhea (28%), stomatitis (26%), fatigue (21%) and musculoskeletal pain (21%). PFS of LUMAKRAS 240 mg daily plus Vectibix (n=53) compared to investigator's choice was not statistically significant.
The KRAS G12C mutation is present in approximately 3-5% of colorectal cancers as determined by an FDA-approved biomarker test. 3-5 This emphasizes the important role of comprehensive biomarker testing in mCRC. By detecting an actionable mutation, eligible patients are now able to receive a corresponding targeted therapy that may lead to improved responses.
"In metastatic colorectal cancer, KRAS mutations are historically associated with worse mortality rates and inferior outcomes compared to non-mutated tumors, and standard treatment options have shown minimal benefit," said Marwan G. Fakih , M.D., primary study investigator and co-director of the Gastrointestinal Cancer Program, City of Hope. 3-6 "Designed for dual blockade of KRAS G12C and EGFR pathways, the combination of sotorasib plus panitumumab provides a needed new treatment option to better overcome cancer's escape mechanisms. The CodeBreaK 300 study showed superior progression-free survival compared to the investigated standard of care and represents a clinically meaningful benefit for patients with KRAS G12C-mutated metastatic colorectal cancer."
"There is an immense need for continued innovation and precision medicine to help address metastatic colorectal cancer," said Michael Sapienza , Chief Executive Officer of the Colorectal Cancer Alliance. "This new combination approach is an important breakthrough for patients with KRAS G12C-mutated metastatic colorectal cancer, offering a new beneficial treatment option for patients living with this devastating and challenging disease."
* Investigator's choice for SOC included trifluridine/tipiracil or regorafenib.
About CodeBreaK 300
The CodeBreaK 300 trial enrolled 160 participants and compared LUMAKRAS ® (sotorasib) at doses of 960 mg and 240 mg in combination with Vectibix ® (panitumumab) to investigator's choice of standard of care (trifluridine/tipiracil or regorafenib) in patients with chemorefractory KRAS G12C-mutated metastatic colorectal cancer (mCRC). The study met its primary endpoint showing improved progression-free survival (PFS), and the key secondary endpoints of overall survival (OS) and overall response rate (ORR) also favored the combination.
About mCRC and the KRAS G12C Mutation
Colorectal cancer (CRC) is the second leading cause of cancer deaths worldwide, comprising 11% of all cancer diagnoses. 7 It is also the third most commonly diagnosed cancer globally. 8
Patients with previously treated mCRC need more effective treatment options. For patients in the third-line setting, standard therapies yield median OS times of less than one year, and patients' response rates are less than 10%. 9
KRAS mutations are among the most common genetic alterations in CRC, with the KRAS G12C mutation present in approximately 3-5% of CRC cases as determined by a U.S. Food and Drug Administration (FDA)-approved biomarker test. 3-5
About LUMAKRAS ® (sotorasib) in Combination with Vectibix ® (panitumumab)
In the U.S., LUMAKRAS is now approved in combination with Vectibix ® (panitumumab) for the treatment of adult patients with KRAS G12C-mutated mCRC, as determined by an FDA-approved test, who have received prior fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy. This targeted therapy combines LUMAKRAS, a KRAS G12C inhibitor, with Vectibix, a monoclonal anti-EGFR antibody. The recommended dose of LUMAKRAS is 960 mg daily, and the recommended dose of Vectibix is 6 mg/kg IV q2 weeks.
About LUMAKRAS ® /LUMYKRAS ® (sotorasib)
LUMAKRAS received accelerated approval from the FDA on May 28, 2021 . The FDA completed its review of Amgen's supplemental New Drug Application (sNDA) seeking full approval of LUMAKRAS on December 26, 2023 , which resulted in a complete response letter. In addition, the FDA concluded that the dose comparison postmarketing requirement (PMR) issued at the time of LUMAKRAS accelerated approval, to compare the safety and efficacy of LUMAKRAS 960 mg daily dose versus a lower daily dose, has been fulfilled. The company said LUMAKRAS at 960 mg once-daily will remain the dose for patients with KRAS G12C-mutated non-small cell lung cancer (NSCLC) under accelerated approval. The FDA also issued a new PMR for an additional confirmatory study to support full approval that will be completed no later than February 2028.
About Vectibix ® (panitumumab)
Vectibix is the first and only human monoclonal anti-EGFR antibody fully approved by the FDA for the treatment of mCRC. Vectibix was approved in the U.S. in September 2006 as a monotherapy for the treatment of patients with EGFR-expressing mCRC following disease progression after prior treatment with fluoropyrimidine-, oxaliplatin- and irinotecan-containing chemotherapy.
In May 2014, the FDA approved Vectibix for use in combination with FOLFOX as first-line treatment in patients with wild-type KRAS (exon 2) mCRC. With this approval, Vectibix became the first-and-only anti-EGFR biologic therapy indicated for use with FOLFOX, one of the most commonly used chemotherapy regimens, in first-line treatment of mCRC for patients with wild-type KRAS mCRC.
In June 2017, the FDA approved a refined indication for Vectibix for use in patients with wild-type RAS (defined as wild-type in both KRAS and NRAS as determined by an FDA-approved test for this use) mCRC, specifically as first-line therapy in combination with FOLFOX and as monotherapy following disease progression after prior treatment with fluoropyrimidine-, oxaliplatin- and irinotecan-containing chemotherapy.
LUMAKRAS ® (sotorasib) in Combination with Vectibix ® (panitumumab) U.S. Indication
Vectibix ® in combination with sotorasib, is indicated for the treatment of adult patients with KRAS G12C -mutated mCRC, as determined by an FDA-approved test, who have received prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.
LIMITATIONS OF USE
Vectibix ® is not indicated for the treatment of patients with RAS- mutant mCRC unless used in combination with sotorasib in KRAS G12C-mutated mCRC. Vectibix ® is not indicated for the treatment of patients with mCRC for whom RAS mutation status is unknown.
IMPORTANT SAFETY INFORMATION FOR LUMAKRAS ® (SOTORASIB)
Hepatotoxicity
- LUMAKRAS ® can cause hepatotoxicity and increased ALT or AST which may lead to drug-induced liver injury and hepatitis.
- In the pooled safety population of NSCLC patients who received single agent LUMAKRAS ® 960 mg hepatotoxicity occurred in 27% of patients, of which 16% were Grade ≥ 3. Among patients with hepatotoxicity who required dosage modifications, 64% required treatment with corticosteroids.
- In this pooled safety population of NSCLC patients who received single agent LUMAKRAS ® 960 mg, 17% of patients who received LUMAKRAS ® had increased alanine aminotransferase (ALT)/increased aspartate aminotransferase (AST); of which 9% were Grade ≥ 3. The median time to first onset of increased ALT/AST was 6.3 weeks (range: 0.4 to 42). Increased ALT/AST leading to dose interruption or reduction occurred in 9% of patients treated with LUMAKRAS ® . LUMAKRAS ® was permanently discontinued due to increased ALT/AST in 2.7% of patients. Drug-induced liver injury occurred in 1.6% (all grades) including 1.3% (Grade ≥ 3).
- In this pooled safety population of NSCLC patients who received single agent LUMAKRAS ® 960 mg, a total of 40% patients with recent (≤ 3 months) immunotherapy prior to starting LUMAKRAS ® had an event of hepatotoxicity. An event of hepatotoxicity was observed in 18% of patients who started LUMAKRAS ® more than 3 months after last dose of immunotherapy and in 17% of those who never received immunotherapy. Regardless of time from prior immunotherapy, 94% of hepatotoxicity events improved or resolved with dosage modification of LUMAKRAS ® , with or without corticosteroid treatment.
- Monitor liver function tests (ALT, AST, alkaline phosphatase and total bilirubin) prior to the start of LUMAKRAS ® , every 3 weeks for the first 3 months of treatment, then once a month or as clinically indicated, with more frequent testing in patients who develop transaminase and/or bilirubin elevations. Withhold, reduce the dose or permanently discontinue LUMAKRAS ® based on severity of the adverse reaction. Consider administering systemic corticosteroids for the management of hepatotoxicity.
Interstitial Lung Disease (ILD)/Pneumonitis
- LUMAKRAS ® can cause ILD/pneumonitis that can be fatal.
- In the pooled safety population of NSCLC patients who received single agent LUMAKRAS ® 960 mg ILD/pneumonitis occurred in 2.2% of patients, of which 1.1% were Grade ≥ 3, and 1 case was fatal. The median time to first onset for ILD/pneumonitis was 8.6 weeks (range: 2.1 to 36.7 weeks). LUMAKRAS ® was permanently discontinued due to ILD/pneumonitis in 1.3% of LUMAKRAS ® -treated patients. Monitor patients for new or worsening pulmonary symptoms indicative of ILD/pneumonitis (e.g., dyspnea, cough, fever). Immediately withhold LUMAKRAS ® in patients with suspected ILD/pneumonitis and permanently discontinue LUMAKRAS ® if no other potential causes of ILD/pneumonitis are identified.
Most Common Adverse Reactions
- The most common adverse reactions ≥ 20% were diarrhea, musculoskeletal pain, nausea, fatigue, hepatotoxicity, and cough.
Drug Interactions
- Advise patients to inform their healthcare provider of all concomitant medications, including prescription medicines, over-the-counter drugs, vitamins, dietary and herbal products.
- Inform patients to avoid proton pump inhibitors and H2 receptor antagonists while taking LUMAKRAS ® .
- If coadministration with an acid-reducing agent cannot be avoided, inform patients to take LUMAKRAS ® 4 hours before or 10 hours after a locally acting antacid.
Please see accompanying LUMAKRAS ® full Prescribing Information .
IMPORTANT SAFETY INFORMATION FOR VECTIBIX ® (PANITUMUMAB)
BOXED WARNING: DERMATOLOGIC TOXICITY
Dermatologic Toxicity: Dermatologic toxicities occurred in 90% of patients and were severe (NCI-CTC Grade 3 and higher) in 15% of patients receiving Vectibix ® monotherapy
- Vectibix ® can cause dermatologic toxicity, which may be severe. Clinical manifestations included, but were not limited to, acneiform dermatitis, pruritus, erythema, rash, skin exfoliation, paronychia, dry skin, and skin fissures.
- Among 229 patients who received Vectibix ® as monotherapy, dermatologic toxicity occurred in 90% including Grade 3 (15%). Among 585 patients who received Vectibix ® in combination with FOLFOX, dermatologic toxicity occurred in 96% including Grade 4 (1%) and Grade 3 (32%). In 126 patients receiving Vectibix ® in combination with sotorasib across clinical studies, dermatologic toxicities occurred in 94%, including Grade 3 (16%) of patients.
- Monitor patients who develop dermatologic or soft tissue toxicities while receiving Vectibix ® for the development of inflammatory or infectious sequelae. Life-threatening and fatal infectious complications including necrotizing fasciitis, abscesses, and sepsis have been observed in patients treated with Vectibix ® . Life-threatening and fatal bullous mucocutaneous disease with blisters, erosions, and skin sloughing has also been observed in patients treated with Vectibix ® . It could not be determined whether these mucocutaneous adverse reactions were directly related to EGFR inhibition or to idiosyncratic immune-related effects (eg, Stevens Johnson syndrome or toxic epidermal necrolysis). Withhold or discontinue Vectibix ® for dermatologic or soft tissue toxicity associated with severe or life-threatening inflammatory or infectious complications. Dose modifications for Vectibix ® concerning dermatologic toxicity are provided
- Vectibix ® monotherapy or in combination with oxaliplatin-based chemotherapy is not indicated for the treatment of patients with colorectal cancer that harbor somatic RAS mutations in exon 2 (codons 12 and 13), exon 3 (codons 59 and 61), and exon 4 (codons 117 and 146) of either KRAS or NRAS and hereafter is referred to as " RAS. "
- Retrospective subset analyses across several randomized clinical trials were conducted to investigate the role of RAS mutations on the clinical effects of anti-EGFR-directed monoclonal antibodies (panitumumab or cetuximab). Anti-EGFR antibodies in patients with tumors containing RAS mutations resulted in exposing those patients to anti-EGFR related adverse reactions without clinical benefit from these agents. Additionally, in Study 20050203, 272 patients with RAS -mutant mCRC tumors received Vectibix ® in combination with FOLFOX and 276 patients received FOLFOX alone. In an exploratory subgroup analysis , OS was shorter (HR = 1.21, 95% CI: 1.01-1.45) in patients with RAS -mutant mCRC who received Vectibix ® and FOLFOX versus FOLFOX alone.
- Vectibix ® can cause progressively decreasing serum magnesium levels leading to severe (Grade 3 or 4) hypomagnesemia. Among 229 patients who received Vectibix ® as monotherapy, hypomagnesemia occurred in 38% including Grade 4 (1.3%) and Grade 3 (2.6%). Among 585 patients who received Vectibix ® in combination with FOLFOX, hypomagnesemia occurred in 51% including Grade 4 (5%) and Grade 3 (6%). In 126 patients receiving Vectibix ® in combination with sotorasib across clinical studies, decreased magnesium occurred in 69%, including Grade 4 (2.4%) and Grade 3 (14%).
- Monitor patients for hypomagnesemia and hypocalcemia prior to initiating Vectibix ® treatment, periodically during Vectibix ® treatment, and for up to 8 weeks after the completion of treatment. Other electrolyte disturbances, including hypokalemia, have also been observed. Replete magnesium and other electrolytes as appropriate.
- In Study 20020408, 4% of patients experienced infusion reactions and 1% of patients experienced severe infusion reactions (NCI-CTC Grade 3-4). Infusion reactions, manifesting as fever, chills, dyspnea, bronchospasm, and hypotension, can occur following Vectibix ® administration. Fatal infusion reactions occurred in postmarketing experience. Terminate the infusion for severe infusion reactions.
- Severe diarrhea and dehydration, leading to acute renal failure and other complications, have been observed in patients treated with Vectibix ® . Among 229 patients who received Vectibix ® as monotherapy, acute renal failure occurred in 2% including Grades 3 or 4 (2%). Among 585 patients who received Vectibix ® in combination with FOLFOX, acute renal failure occurred in 2% including Grade 3 or 4 (2%). In 126 patients receiving Vectibix ® in combination with sotorasib across clinical studies, acute renal failure occurred in 3.2%, including Grade 3 (0.8%). Monitor patients for diarrhea and dehydration, provide supportive care (including anti-emetic or anti-diarrheal therapy) as needed, and withhold Vectibix ® if necessary.
- Fatal and nonfatal cases of interstitial lung disease (ILD) (1%) and pulmonary fibrosis have been observed in patients treated with Vectibix ® . Pulmonary fibrosis occurred in less than 1% (2/1467) of patients enrolled in clinical studies of Vectibix ® . Grade 1 ILD/pneumonitis occurred in 0.8% (1/126) of patients enrolled in clinical studies of Vectibix ® in combination with sotorasib. In the event of acute onset or worsening of pulmonary symptoms interrupt Vectibix ® therapy. Discontinue Vectibix ® therapy if ILD is confirmed.
- In patients with a history of interstitial pneumonitis or pulmonary fibrosis, or evidence of interstitial pneumonitis or pulmonary fibrosis, the benefits of therapy with Vectibix ® versus the risk of pulmonary complications must be carefully considered.
- Exposure to sunlight can exacerbate dermatologic toxicity. Advise patients to wear sunscreen and hats and limit sun exposure while receiving Vectibix ® .
- Serious cases of keratitis, ulcerative keratitis, and corneal perforation have occurred with Vectibix ® use. Among 585 patients who received Vectibix ® in combination with FOLFOX, keratitis occurred in 0.3%. In 126 patients receiving Vectibix ® in combination with sotorasib across clinical studies, keratitis occurred in 1.6%, ulcerative keratitis occurred in 0.8%, and vernal keratoconjunctivitis in 0.8% (all were Grade 1-2). Monitor for evidence of keratitis, ulcerative keratitis, or corneal perforation. Interrupt or discontinue Vectibix ® therapy for acute or worsening keratitis, ulcerative keratitis, or corneal perforation.
- In an interim analysis of an open-label, multicenter, randomized clinical trial in the first-line setting in patients with mCRC, the addition of Vectibix ® to the combination of bevacizumab and chemotherapy resulted in decreased OS and increased incidence of NCI-CTC Grade 3-5 (87% vs 72%) adverse reactions. NCI-CTC Grade 3-4 adverse reactions occurring at a higher rate in Vectibix ® -treated patients included rash/acneiform dermatitis (26% vs 1%), diarrhea (23% vs 12%), dehydration (16% vs 5%), primarily occurring in patients with diarrhea, hypokalemia (10% vs 4%), stomatitis/mucositis (4% vs ® -treated patients (7% vs 3%) and included fatal events in three ( ® -treated patients.
- As a result of the toxicities experienced, patients randomized to Vectibix ® , bevacizumab, and chemotherapy received a lower mean relative dose intensity of each chemotherapeutic agent (oxaliplatin, irinotecan, bolus 5-FU, and/or infusional 5-FU) over the first 24 weeks on study compared with those randomized to bevacizumab and chemotherapy.
- Based on data from animal studies and its mechanism of action, Vectibix ® can cause fetal harm when administered to a pregnant woman. When given during organogenesis, panitumumab administration resulted in embryolethality in cynomolgus monkeys at exposures approximately 1.25 to 5 times the recommended human dose. Advise pregnant women and females of reproductive potential of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment, and for at least 2 months after the last dose of Vectibix ® .
- In monotherapy, the most commonly reported adverse reactions (≥ 20%) in patients with Vectibix ® were skin rash with variable presentations, paronychia, fatigue, nausea, and diarrhea.
- The most commonly reported adverse reactions (≥ 20%) with Vectibix ® + FOLFOX were diarrhea, stomatitis, mucosal inflammation, asthenia, paronychia, anorexia, hypomagnesemia, hypokalemia, rash, acneiform dermatitis, pruritus, and dry skin. Serious adverse reactions (≥ 2% difference between treatment arms) were diarrhea and dehydration.
- The most common adverse reactions (≥ 20%) in patients receiving Vectibix ® in combination with sotorasib 960 mg were rash, dry skin, diarrhea, stomatitis, fatigue and musculoskeletal pain.
Please see full Prescribing Information , including Boxed WARNING.
About Amgen
Amgen discovers, develops, manufactures and delivers innovative medicines to help millions of patients in their fight against some of the world's toughest diseases. More than 40 years ago, Amgen helped to establish the biotechnology industry and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what's known today. Amgen is advancing a broad and deep pipeline that builds on its existing portfolio of medicines to treat cancer, heart disease, osteoporosis, inflammatory diseases and rare diseases.
In 2024, Amgen was named one of the "World's Most Innovative Companies" by Fast Company and one of "America's Best Large Employers" by Forbes, among other external recognitions . Amgen is one of the 30 companies that comprise the Dow Jones Industrial Average ® , and it is also part of the Nasdaq-100 Index ® , which includes the largest and most innovative non-financial companies listed on the Nasdaq Stock Market based on market capitalization.
For more information, visit Amgen.com and follow Amgen on X , LinkedIn , Instagram , TikTok , YouTube and Threads .
Amgen Forward-Looking Statements
This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including any statements on the outcome, benefits and synergies of collaborations, or potential collaborations, with any other company (including BeiGene, Ltd. or Kyowa Kirin Co., Ltd.), the performance of Otezla ® (apremilast) (including anticipated Otezla sales growth and the timing of non-GAAP EPS accretion), our acquisitions of Teneobio, Inc., ChemoCentryx, Inc., or Horizon Therapeutics plc (including the prospective performance and outlook of Horizon's business, performance and opportunities, any potential strategic benefits, synergies or opportunities expected as a result of such acquisition, and any projected impacts from the Horizon acquisition on our acquisition-related expenses going forward), as well as estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes, effects of pandemics or other widespread health problems on our business, outcomes, progress, and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen, including our most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.
No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for us to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future.
Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints we have selected. We develop product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as we may have believed at the time of entering into such relationship. Also, we or others could identify safety, side effects or manufacturing problems with our products, including our devices, after they are on the market.
Our results may be affected by our ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments involving current and future products, sales growth of recently launched products, competition from other products including biosimilars, difficulties or delays in manufacturing our products and global economic conditions. In addition, sales of our products are affected by pricing pressure, political and public scrutiny and reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment. Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. Our business may be impacted by government investigations, litigation and product liability claims. In addition, our business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. If we fail to meet the compliance obligations in the corporate integrity agreement between us and the U.S. government, we could become subject to significant sanctions. Further, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors, or we may fail to prevail in present and future intellectual property litigation. We perform a substantial amount of our commercial manufacturing activities at a few key facilities, including in Puerto Rico , and also depend on third parties for a portion of our manufacturing activities, and limits on supply may constrain sales of certain of our current products and product candidate development. An outbreak of disease or similar public health threat, such as COVID-19, and the public and governmental effort to mitigate against the spread of such disease, could have a significant adverse effect on the supply of materials for our manufacturing activities, the distribution of our products, the commercialization of our product candidates, and our clinical trial operations, and any such events may have a material adverse effect on our product development, product sales, business and results of operations. We rely on collaborations with third parties for the development of some of our product candidates and for the commercialization and sales of some of our commercial products. In addition, we compete with other companies with respect to many of our marketed products as well as for the discovery and development of new products. Further, some raw materials, medical devices and component parts for our products are supplied by sole third-party suppliers. Certain of our distributors, customers and payers have substantial purchasing leverage in their dealings with us. The discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations. Our efforts to collaborate with or acquire other companies, products or technology, and to integrate the operations of companies or to support the products or technology we have acquired, may not be successful. There can be no guarantee that we will be able to realize any of the strategic benefits, synergies or opportunities arising from the Horizon acquisition, and such benefits, synergies or opportunities may take longer to realize than expected. We may not be able to successfully integrate Horizon, and such integration may take longer, be more difficult or cost more than expected. A breakdown, cyberattack or information security breach of our information technology systems could compromise the confidentiality, integrity and availability of our systems and our data. Our stock price is volatile and may be affected by a number of events. Our business and operations may be negatively affected by the failure, or perceived failure, of achieving our environmental, social and governance objectives. The effects of global climate change and related natural disasters could negatively affect our business and operations. Global economic conditions may magnify certain risks that affect our business. Our business performance could affect or limit the ability of our Board of Directors to declare a dividend or our ability to pay a dividend or repurchase our common stock. We may not be able to access the capital and credit markets on terms that are favorable to us, or at all.
CONTACT: Amgen, Thousand Oaks
Elissa Snook , 609-251-1407 (media)
Justin Claeys , 805-313-9775 (investors)
References
- Fakih M, et al. N Engl J Med. 2023;389(23): 2125- 2139.
- Biller L, et al. JAMA . 2021;325(7):669-685.
- Neumann J, et al. Pathol Res Pract . 2009;205(12):858-862.
- Jones RP, et al. Br J Cancer . 2017;116(7):923-929.
- Wiesweg M, et al. Oncogene . 2019;38(16):2953-2966.
- Fakih M, et al. The Oncologist . 2022;27(8):663–674.
- Rawla P, et al. Prz Gastroenterol . 2019;14(2):89-103.
- World Health Organization. 2022 Statistics. https://www.who.int/en/news-room/fact-sheets/detail/cancer . Accessed on August 20, 2024 .
- Prager GW, et al. N Engl J Med . 2023;388(18):1657-1667.
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SOURCE Amgen

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Sirona Biochem Showcases TFC-1326 in Stonegate Healthcare's Landmark Report
Sirona Biochem Corp. (TSX-V: SBM) (FSE: ZSB) (OTC: SRBCF) is excited to announce that its cutting-edge anti-aging compound, TFC-1326, has been highlighted in Stonegate Healthcare Partners' latest research report. The publication, titled "Sirona Biochem's TFC-1326 Clinical Data Versus Retinoid Clinical Data," provides an extensive evaluation of TFC-1326's clinical trial performance, setting it apart from traditional retinoid treatments.
The report outlines the remarkable benefits of TFC-1326, including:
- Boosting skin radiance
- Significantly reducing wrinkle depth and volume
- Enhancing skin elasticity and firmness
- Ensuring deep hydration with no irritation
Stonegate Healthcare's analysis underscores TFC-1326's ability to deliver rapid, consistent results while also providing potent antioxidant and anti-inflammatory benefits. Unlike traditional retinoids, which can cause irritation, TFC-1326 is ideal for all skin types, including sensitive skin, redefining what's possible in the $12.5 billion global anti-aging market.
"This recognition by Stonegate Healthcare Partners highlights the transformative potential of TFC-1326," said Dr. Verrico, CEO of Sirona Biochem. "Our mission has always been to push the boundaries of skincare science, and we are proud to see our innovation recognized in this detailed analysis."
The publication positions TFC-1326 as a disruptive force in cosmetic dermatology, offering a highly effective, user-friendly alternative to conventional treatments. This achievement reflects Sirona Biochem's ongoing commitment to pioneering advanced solutions in the skincare industry.
Access the Full Report Here: https://shp.reportablenews.com/pr/stonegate-healthcare-research-update-on-sirona
https://stonegateinc.com/download/stonegate-healthcare-partners-announces-publication-of-a-literature-review-on-anti-aging-dermatology/?wpdmdl=1269&refresh=677efef279b251736376050
About Sirona Biochem Sirona is a cosmetic ingredient and drug discovery company with a proprietary platform technology. Sirona specializes in stabilizing carbohydrate molecules with the goal of improving efficacy and safety. New compounds are patented for maximum revenue potential. Sirona's compounds are licensed to leading companies around the world in return for licensing fees, milestone fees, and ongoing royalty payments. Sirona's laboratory, TFChem, is in France and is the recipient of multiple French national scientific awards and European Union and French government grants. For more information, please visit www.sironabiochem.com .
Forward Looking Statements This news release includes certain statements that may be deemed "forward-looking statements." All statements in this news release, other than statements of historical facts, that address events or developments that the Company expects to occur, are forward-looking statements. Forward-looking statements are statements that are not historical facts and are generally, but not always, identified by the words "expects," "plans," "anticipates," "believes," "intends," "estimates," "projects," "potential" and similar expressions, or that events or conditions "will," "would," "may," "could" or "should" occur. Although the Company believes the expectations expressed in such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of future performance, and actual results may differ materially from those in the forward-looking statements. Factors that could cause the actual results to differ materially from those in forward-looking statements include market prices, continued availability of capital and financing, and general economic, market or business conditions. Investors are cautioned that any such statements are not guarantees of future performance, and actual results or developments may differ materially from those projected in the forward-looking statements. Forward-looking statements are based on the beliefs, estimates, and opinions of the Company's management on the date the statements are made. Except as required by applicable securities laws, the Company undertakes no obligation to update these forward-looking statements in the event that management's beliefs, estimates, or opinions, or other factors, should change.
Contact Information: Christopher Hopton
Chief Financial Officer
Sirona Biochem Corp.
Phone: (604) 641-4466
Email: info@sironabiochem.com
Website: www.sironabiochem.com
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Top 4 Canadian Biotech Stocks (Updated January 2025)
Biotech is a dynamic industry that is driving scientific advancements and innovation in healthcare. In Canada, the biotech industry is home to companies pursuing cutting-edge therapies and medical technologies.
According to Grandview Research, the global biotech market is expected to grow at a compound annual growth rate of 13.96 percent between 2024 and 2030 to reach a value of US$3.08 trillion.
Here, the Investing News Network profiles the five best-performing Canadian biotech stocks based on their year-on-year gains.
Data on Canadian biotech stocks was collected on January 14, 2025, using TradingView's stock screener. Only companies with market capitalizations of over C$50 million at that time were considered. Companies on the TSX, TSXV and CSE were considered, but no TSXV-listed stocks made the list this time. Read on to learn what's been driving these biotech firms.
1. Bright Minds Biosciences (CSE:DRUG)
Year-on-year gain: 2,131 percent
Market cap: C$391.38 million
Share price: C$56.00
Bright Minds Biosciences is focused on developing novel treatments for neuropsychiatric disorders and pain. Its portfolio consists of serotonin agonists designed to target neurocircuit abnormalities that make disorders like epilepsy, post-traumatic stress disorder and depression difficult to treat.
The company's drugs have been designed to potentially retain the powerful therapeutic aspects of psychedelic and other serotonergic compounds, while minimizing the side effects, thereby creating superior drugs to first-generation compounds such as psilocybin.
Bright Minds is in Phase 2 clinical trials of its candidate BMB-101 in patients with classic absence epilepsy and developmental epileptic encephalopathy.
On October 15, the company's stock price surged nearly 1,500 percent in a single session. While Bright Minds didn't have news of its own, the move was likely influenced by global pharmaceutical company Lundbeck's announcement of intention to acquire Longboard Pharmaceuticals, which has a similar drug candidate. Bright Minds closed a non-brokered private placement that included participation from a group of healthcare investors on November 4, 2024.
2. ME Therapeutics Holdings (CSE:METX)
Year-on-year gain: 369.42 percent
Market cap: C$95.72 million
Share price: C$5.68
ME Therapeutics Holdings is a biotechnology company focused on developing cancer-fighting drug candidates that can increase the efficacy of current immuno-oncology drugs by targeting suppressive myeloid cells, which have been found to hinder the effectiveness of existing immuno-oncology treatments. Immuno-oncology is a relatively new area of cancer drug research and has shown promising results when used to treat cancer with low survival rates.
In December 2023, the company shared research done in collaboration with Dr. Kenneth Harder at the University of British Columbia suggesting ME Therapeutics' antibody, h1B11-12, successfully blocks a protein that fuels breast and colon cancer growth (G-CSF). Trial planning efforts are ongoing, and the company expects development of a cell line for future production of the drug to be finished in the latter half of 2025.
In addition, the company is part of an ongoing collaborative effort to develop therapeutic MRNA delivery methods to myeloid cells with NanoVation Therapeutics, a biotech company that develops customized nucleic acid and lipid nanoparticle technologies to empower genetic medicine. The collaboration has already resulted in two new MRNA formulations, for which testing began on October 4.
3. Medicenna (TSX:MDNA)
Year-on-year gain: 217.07 percent
Market cap: C$104.81 million
Share price: C$1.30
Medicenna is a clinical-stage immuno-oncology company specializing in the development of innovative therapies for patients with challenging unmet needs. Its focus is on creating novel, highly selective versions of cytokines — small proteins that play a crucial role in regulating immune responses — such as IL-2, IL-4 and IL-13, which it refers to as "Superkines" and "empowered superkines."
Interleukins, which Medicenna says are at the core of its therapies, are groups of cytokines. The company's interleukins are engineered to fuse with specific molecules to optimize their function. Its therapies treat solid tumors, which have a low response rate to conventional cancer treatments, and autoimmune and neuroinflammatory diseases.
Medicenna's lead candidate, MDNA11, has demonstrated therapeutic activity and an acceptable safety profile during clinical trials of monotherapy dose escalation in treating patients with advanced solid tumors.
On December 5, the company shared a clinical update for its Phase 1/2 ABILITY-1 study, which is testing MDNA11 in combination with Merck's KEYTRUDA, revealing one patient in the study had a complete response after receiving eight weeks of treatment.
4. Cardiol Therapeutics (TSX:CRDL)
Year-on-year gain: 27.86 percent
Market cap: C$149.33 million
Share price: C$1.79
Cardiol Therapeutics is a biopharma company developing innovative treatments for inflammation and fibrosis in cardiovascular conditions. Its research is concentrated on pericarditis, which is inflammation of the membrane surrounding the heart; myocarditis, or inflammation of the heart muscle; and heart failure.
Cardiol currently has two drug candidates in its pipeline. CardiolRx, the company's lead candidate, received an orphan drug destination in February 2024.
Cardol shared the results of its Phase 2 open-label pilot study of CardiolRx in patients with symptomatic recurrent pericarditis at the American Heart Association Scientific Sessions in November 2024. Findings indicated that CardiolRx significantly reduced pericardial pain in patients, with most experiencing relief within 5 days, and that the benefits were sustained over the extended 26 week study. The treatment also lowered inflammation and prevented recurring episodes, leading to a significant decrease in pericarditis occurrences.
The biotech company is also developing CRD-38, a drug formulation of cannabidiol that is administered subcutaneously for treating heart failure.
Don’t forget to follow us @INN_LifeScience for real-time news updates!
Securities Disclosure: I, Meagen Seatter, hold no direct investment interest in any company mentioned in this article.
Editorial Disclosure: Cardiol Therapeutics is a client of the Investing News Network. This article is not paid-for content.
Cizzle Brands Launching Spoken Nutrition as its Latest Performance-Driven Brand for Athletes
Spoken Nutrition™ is a premium brand of athlete-grade nutraceuticals that carry the prestigious NSF Certified for Sport® qualification, making Spoken products eligible for use by athletes in several major-league and minor-league organizations, as well as the NCAA. With purchase orders secured from many professional sports teams, including multiple MLB teams for use during Spring Training leading into the 2025 regular baseball season, the launch of Spoken Nutrition™ cements Cizzle Brands Corporation as a global leader in sports nutrition.
Cizzle Brands Corporation (Cboe Canada: CZZL) ( the "Company or "Cizzle Brands") , the sports nutrition company elevating the game in health and wellness, is pleased to announce the launch of its premium NSF Certified for Sport ® nutraceutical line of products, Spoken Nutrition™ (" Spoken ").
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250114466855/en/

NSF has granted its Certified for Sport® designation to Spoken Nutrition's products, which is reflected on the organization's official website. These product listings with additional details about each can be accessed through this link. (Photo: Business Wire)
Introduction to Spoken Nutrition
Spoken's ™ line of products is composed of nutritional supplements formulated by the world's leading performance coaches, dieticians, nutritionists, and functional medicine doctors to meet the needs of their professional athletes.
The team that formulated Spoken's ™ products includes Dr. Matt Frakes (LSU Dietician), Carl Bergstrom (Director of Performance for NBA All-Star, Steph Curry), Brianne Brown (University of Miami Strength & Conditioning Coach), Alan Bishop (University of Houston Director of Men's Basketball Sports Performance), David Lawrence (Strength Coach to Six NFL Super Bowl Winners), Ben Prentiss (Experienced NHL Strength Coach), Dr. Jordan Shallow (Doctor of Chiropractic and Strength Coach to Elite Athletes), Dr. Sachin Patel (Functional Medicine Doctor), and Cizzle Brands' Chief Performance Officer, Andy O'Brien.
Mr. O'Brien was nicknamed "The Muscle Whisperer" by Sportsnet in 2015, highlighting his work as a trainer to NHL superstar Sidney Crosby, Olympic medallist figure skater Patrick Chan, women's hockey legend Hayley Wickenheiser, and Olympic swimmer Dara Torres. Mr. O'Brien has also held coaching and consultancy roles for the Pittsburgh Penguins and Florida Panthers in the National Hockey League.
All Spoken ™ products carry the NSF Certified for Sport ® designation, a rigorous certification program that confirms sports supplements and sports nutritional products do not contain substances banned by many major athletic organizations. Listings of Spoken's ™ products on the NSF website can be seen by clicking on this link .
Last month, Spoken ™ began a soft launch of its product line through introductions to professional team coaches, strength trainers, consultants, advisors, and dieticians. This included a one-hour presentation on Spoken Nutrition ™ delivered to the majority of MLB strength coaches during the Winter MLB Meetings. Several MLB teams have already placed orders for Spoken Nutrition products.
Additional information about Spoken Nutrition ™ can be found on its website at http://spokennutrition.com
Market and Opportunity Size
According to a study published in the National Institutes of Health database in 2023, the global market size for dietary supplements grew from USD $82 billion to USD $149.5 billion in 2021, with a forecasted compound annual growth rate of 8.9% that is expected to drive the market size to USD $308 billion in 2028.
Another study indicated that 2021 was a record year for usage of dietary supplements, with 80% of U.S. adults taking such supplements in that year.
Labelling accuracy of sports supplements remains a persisting issue, with a 2023 study by the University of Mississippi revealing that nearly 90% of sports supplements are inaccurately labelled.
By virtue of the NSF Certified for Sport® label on Spoken Nutrition ™ products, not only can consumers have trust in all Spoken ™ products, the certification along with the involvement of Dr. Frakes, Ms. Brown, and Mr. Bishop well-positions Spoken ™ to serve the nutritional needs of the over 520,000 NCAA collegiate athletes in the United States.
Overview of Spoken Nutrition Products
Spoken ™ Sleep Builder: containing only amino acids (such as l-theanine, glycine and glutamine), inositol and three forms of magnesium (orotate, glycerophosphate and glycinate), Spoken ™ Sleep Builder is formulated to help people get more restorative sleep without the use of melatonin, 5-HTP and other herbal supplements.
Spoken ™ Greens: unlike other greens products that take a kitchen-sink approach to formulation, Spoken™ Greens contains only 20 high-impact, nutrient-rich ingredients in quantities that will actually make a difference to your health.
Spoken ™ Aminos + ATP: formulated to have a high dose of leucine, added tyrosine and Peak ATP to help with increased muscle protein synthesis, increased dopamine and help with cellular energy.
Spoken ™ Creatine: helps increase body/lean muscle when used in conjunction with a resistance training regimen. It also helps improve strength, power, and performance.
Spoken™ High EPA Fish Oil + D: made from sustainable wild-caught anchovy, sardine, and mackerel low in heavy metals, was intentionally formulated to contain 700mg of EPA (eicosapentaenoic acid) along with 300 mg of DHA (docosahexaenoic acid), Spoken's™ High EPA Fish Oil + D is a very high dose Omega-3 supplement, supplemented with lipase to enhance absorption.
Spoken™ MAG 3: formulated to be one of the best sources of magnesium for cardiovascular, cognitive, muscular, and brain health. Spoken™ MAG 3 not only increases magnesium levels in the brain but also raises blood serum magnesium levels. Each serving contains 225 mg of elemental magnesium from three highly bioavailable forms: Magnesium Glycinate, Magnesium Malate, and ATA Mg®, a patented acetyl taurinate magnesium salt.
Spoken™ Pro Resolving Mediators + EPA/DHA: formulated to manage pain, help our bodies avoid the ravages of injury and promote a natural, balanced recovery process. Each capsule of Spoken™ Pro Resolving Mediators + EPA/DHA contains 14-HDHA, 17-HDHA, and 18-HEPE, along with their source materials, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA).
Spoken™ Vitamin D3 + K1/K2: each capsule of Spoken™ Vitamin D3 + K1/K2 provides 2000 IUs of Vitamin D, along with 120 mcg of K1 and 90 mcg of K2.
Spoken™ Essential Daily Packs: formulated to be the essential, all-in-one foundational vitamin and nutritional supplement for athletes and people living an active lifestyle, Spoken™ Essential Daily Packs are convenient all-in-one packs designed to fill the critical nutritional gaps that can impact performance.
Spoken™ Grass Fed Whey Protein: the only protein supplement that contains 25 g of grass-fed whey protein, Tendoforte® collagen and 3 g of fat from olive oil or cocoa.
Spoken™ Grass Fed Beef Protein: features 25 grams of complete protein from grass-fed beef bone broth.
More information and purchasing options for Spoken Nutrition products can be found at the following webpage: https://spokennutrition.com/collections/all
Cizzle Brands Chairman and Chief Executive Officer, John Celenza, commented, "The supplements and nutrition products that are actually used by the world's top athletes aren't typically known by name to the general public, as they tend to be niche products which are usually only sold through specialty distributors within the sports nutrition profession. With Spoken, we are making these supplements available to athletes at all levels as well as their coaches and trainers." Mr. Celenza continued, "Spoken Nutrition's team has over a century of combined experience in training and providing nutrition advice for athletes, which gives them the know-how to strategically introduce our products to the decision-makers who place the orders on behalf of teams. In that way, Spoken Nutrition is an ideal complement to our flagship brand CWENCH Hydration™, and can help to fortify Cizzle Brands' leadership place in the sports nutrition industry."
"With over two decades of diverse experience working with the world's top athletes and doing the research to find innovative performance nutrition solutions, I have come to realize that nutrition underpins every aspect of athletic health and performance," said Dana Lis, Performance Nutrition Consultant to the Golden State Warriors. "The elite athletes that I have the honour to work with are incredibly unique in their physiology, and their individual needs must be understood and addressed with precision. Over the years, I've observed how the supplement market often fails to account for these nuances, offering generic solutions in an increasingly saturated and confusing market. This is exactly why the launch of Spoken Nutrition is so meaningful. It is not just yet another supplement line; it is a brand built on science and a deep understanding of the complexities of nutritional physiology and performance, as well as the practicality of the daily training environment. This commitment to evidence and experienced-based practice is what sets Spoken Nutrition apart - each product is crafted to maximize the impact of key ingredients with no compromises in quality or efficacy. With a dedication to meticulous research, development, attention to detail, and with every product and batch NSF Certified for Sport® , Spoken Nutrition is positioned to be a trusted partner for practitioners and athletes who are dedicated to leaving nothing to chance when it comes to reaching full health and athletic potential."
About Cizzle Brands Corporation
Cizzle Brands Corporation is elevating the game in health and wellness. Through extensive collaboration and testing with leading athletes and trainers across several elite sports, Cizzle Brands has launched two leading product lines in the sports nutrition category: (i) CWENCH Hydration, a better-for-you sports drink that is now carried in over 1,200 stores in Canada, the United States, and Europe; and (ii) Spoken Nutrition, a premium brand of athlete-grade nutraceuticals that carry the prestigious NSF Certified for Sport® qualification. All Cizzle Brands products are designed to help people achieve their best in both competitive sports and in living a healthy, vibrant, active lifestyle.
For more information about Cizzle Brands, please visit: https://www.cizzlebrands.com/
For more information about Spoken Nutrition, please visit: https://spokennutrition.com/
For more information about CWENCH, please visit: https://cwenchhydration.com/
On behalf of the Board of Directors of the Company,
"John Celenza"
John Celenza, Chief Executive Officer
CAUTIONARY NOTE REGARDING FORWARD-LOOKING INFORMATION
This news release contains "forward-looking information" which may include, but is not limited to, information with respect to the activities, events or developments that the Company expects or anticipates will or may occur in the future, such as, but not limited to: new products of the Company and potential sales and distribution opportunities. Such forward-looking information is often, but not always, identified by the use of words and phrases such as "plans", "expects", "is expected", "budget", "scheduled", "estimates", "forecasts", "intends", "anticipates", or "believes" or variations (including negative variations) of such words and phrases, or state that certain actions, events or results "may", "could", "would", "might" or "will" be taken, occur or be achieved. Various assumptions or factors are typically applied in drawing conclusions or making the forecasts or projections set out in forward-looking information. Those assumptions and factors are based on information currently available to the Company.
Forward looking information involves known and unknown risks, uncertainties and other risk factors which may cause the actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking information. Such risks include risks related to increased competition and current global financial conditions, access and supply risks, reliance on key personnel, operational risks, regulatory risks, financing, capitalization and liquidity risks. Although the Company has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking information, there may be other factors that cause results not to be as anticipated, estimated or intended. There can be no assurance that such information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking information. The Company undertakes no obligation, except as otherwise required by law, to update these forward-looking statements if management's beliefs, estimates or opinions, or other factors change.
Readers using news aggregation services may be unable to view the media above. Please access SEDAR+ or the Investors section of the Company's website for a version of this press release containing all published media.
View source version on businesswire.com: https://www.businesswire.com/news/home/20250114466855/en/
For further information, please contact:
Setti Coscarella
Head of Corporate Development
investors@cizzlebrands.com
1-844-588-2088
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