Virtual Investor Conferences, the leading proprietary investor conference series, today announced the agenda for the upcoming Life Sciences Virtual Investor Conference to be held on September 15 th .
Individual investors, institutional investors, advisors, and analysts are invited to attend this virtual event showcasing live executive presentations from companies addressing worldwide opportunities in the life sciences.
REGISTER NOW AT Â : https://bit.ly/3KPH82S
It is recommended that investors pre-register and run the online system check to expedite participation and receive event updates. There is no cost to log-in, attend live presentations and schedule 1x1 meetings with management.
"We are excited to highlight today's innovators from the life science sector," said Jason Paltrowitz, Executive Vice President of Corporate Services at OTC Markets Group. "Our Virtual Investor Conferences continue to provide an efficient platform for these companies to engage and broaden their investor base."
September 15 th
| Eastern Time (ET) | Presentation | Ticker(s) |
| 10:00 AM | Starpharma Holdings Limited | OTCQX: SPHRY | ASX: SPL |
| 10:30 AM | VolitionRx Limited | NYSE: VNRX |
| 11:00 AM | aTyr Pharma, Inc. | Nasdaq: LIFE |
| 11:30 AM | Cloud DX Inc. | OTCQB: CDXFF | TSX-V: CDX |
| 12:00 PM | Cytonics Corporation | Private |
| 12:30 PM | BioHarvest Sciences Inc. | OTCQB: CNVCF | CSE: BHSC |
| 1:00 PM | NovaBay Pharmaceuticals, Inc. | NYSE American: NBY |
| 1:30 PM | Psycheceutical Bioscience, Inc. | OTC Pink: BWVI |
| 2:00 PM | Aethlon Medical, Inc. | Nasdaq: AEMD |
| 2:30 PM | Caladrius Biosciences, Inc. | Nasdaq: CLBS |
| 3:00 PM | HealthBeacon PLC | OTCQX: HBCNF | Euronext Dublin: HBCN |
| 3:30 PM | Else Nutrition Holdings Inc | OTCQX: BABYF | TSX: BABY |
To facilitate investor relations scheduling and to view a complete calendar of Virtual Investor Conferences, please visit www.virtualinvestorconferences.com .
About Virtual Investor Conferences ®
Virtual Investor Conferences (VIC) is the leading proprietary investor conference series that provides an interactive forum for publicly traded companies to seamlessly present directly to investors.
Providing a real-time investor engagement solution, VIC is specifically designed to offer companies more efficient investor access. Replicating the components of an on-site investor conference, VIC offers companies enhanced capabilities to connect with investors, schedule targeted one-on-one meetings and enhance their presentations with dynamic video content. Accelerating the next level of investor engagement, Virtual Investor Conferences delivers leading investor communications to a global network of retail and institutional investors.
Media Contact: Â
OTC Markets Group Inc. +1 (212) 896-4428, media@otcmarkets.com
Virtual Investor Conferences Contact:
John M. Viglotti
SVP Corporate Services, Investor Access
OTC Markets Group
(212) 220-2221
johnv@otcmarkets.com
News Provided by GlobeNewswire via QuoteMedia
Company invites individual and institutional investors, as well as advisors and analysts, to attend real-time, interactive presentations on VirtualInvestorConferences.com
BioHarvest Sciences Inc. (CSE: BHSC) (OTCQB: CNVCF) (FSE:8MV), a biotechnology company focused on growing plant cells without the plant via its patented CELLicitation platform, today announced that Ilan Sobel, Chief Executive Officer, will present live at VirtualInvestorConferences.com on September 15, 2022.
DATE: September 15, 2022
TIME: 12:30 PM ET
LINK: https://bit.ly/3StcgIH
Available for 1x1 meetings: September 16, 19, 20
This will be a live, interactive online event where investors are invited to ask the company questions in real-time. If attendees are not able to join the event live on the day of the conference, an archived webcast will also be made available after the event.
It is recommended that investors pre-register and run the online system check to expedite participation and receive event updates.
Learn more about the event at www.virtualinvestorconferences.com .
Recent BioHarvest Sciences Highlights
About BioHarvest Sciences Inc.
BioHarvest Sciences Inc. (CSE: BHSC) is a fast-growing Biotech firm listed on the Canadian Securities Exchange. BioHarvest has developed a patented bio-cell growth platform technology capable of growing the active and beneficial ingredients in fruit and plants, at industrial scale, without the need to grow the plant itself. This technology is economical, ensures consistency, and avoids the negative environmental impacts associated with traditional agriculture. BioHarvest is currently focused on nutraceuticals and the medicinal cannabis markets. Visit: www.bioharvest.com
About Virtual Investor Conferences ®
Virtual Investor Conferences (VIC) is the leading proprietary investor conference series that provides an interactive forum for publicly traded companies to seamlessly present directly to investors.
Providing a real-time investor engagement solution, VIC is specifically designed to offer companies more efficient investor access. Replicating the components of an on-site investor conference, VIC offers companies enhanced capabilities to connect with investors, schedule targeted one-on-one meetings and enhance their presentations with dynamic video content. Accelerating the next level of investor engagement, Virtual Investor Conferences delivers leading investor communications to a global network of retail and institutional investors.
CONTACTS:
BioHarvest Sciences
Justin Meiklem
Investor Relations
778.686.3855
justin@bioharvest.com
Virtual Investor Conferences
John M. Viglotti
SVP Corporate Services, Investor Access
OTC Markets Group
(212) 220-2221
johnv@otcmarkets.com
News Provided by GlobeNewswire via QuoteMedia
Figure 1
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The Business Intelligence Group has named BioHarvest Sciences (CSE: BHSC) (OTCQB: CNVCF) (FSE: 8MV) as a winner of its 2022 Sustainability Leadership Award. The Business Intelligence Group seeks out and rewards those with vision, creativity and persistence, all hallmarks found in the world's leading companies and individuals across the globe. The awards programs rely on industry leaders who volunteer to read, score and judge nominations.
"By delivering the benefits of plants using a fraction of the energy, water, and land that agriculture would, we see the potential for conserving valuable global resources at a game-changing scale," said BioHarvest CEO Ilan Sobel. "We are gratified to have our sustainability efforts recognized and we are honoured to be among a distinguished list of multiple industries' leaders."
Sustainability is inherent to BioHarvest's Plant CELLicitation platform technology. For example, when applied to indoor Cannabis cultivation, BioHarvest's process delivers the following unrivaled results (based on estimated internal benchmarking at scale versus New Frontiers Data Set for indoor Cannabis operations):
BioHarvest's sustainability achievements for its platform Bio Plant CELLicitation technology have been accomplished by a diverse Research and Development team comprised of five Israeli female scientists with Ph.D. degrees and led by Dr. Yochi Hagay, the co-founder and CTO of the Company.
"My team and I are so proud that we have developed a technology platform that has the ability to not only deliver critical plant metabolites that the human body needs, without growing the plant, but it does so in a way that protects the planet for many generations to come," stated Dr. Hagay.
"We are proud to reward and recognize BioHarvest Sciences for their sustainability efforts," said Maria Jimenez, Chief Nominations Officer of the Business Intelligence Group. "It was clear to our judges that their vision and strategy will continue to deliver results toward a cleaner, more sustainable world. Congratulations!"
Earlier this year, the company announced its ability to produce full-spectrum cannabis in its industrial scale bioreactors, while using approximately 95% less land than agriculture would use to achieve comparable output. This breakthrough in the cannabis industry also combats the two biggest challenges in growth: product consistency and cleanliness.
As part of its long-term sustainability vision, BioHarvest also has its eyes on space. Recently bringing on astronaut Chris Hadfield as an advisor, the company also has a formal partnership with SpaceTango to explore the effects of micro gravity on plant cells and to explore the potential role of its technology supporting space travel and human settlements in space.
About BioHarvest Sciences Inc.
BioHarvest Sciences Inc. (CSE: BHSC) is a fast-growing Biotech firm listed on the Canadian Securities Exchange. BioHarvest has developed a patented bio-cell growth platform technology capable of growing the active and beneficial ingredients in fruit and plants, at industrial scale, without the need to grow the plant itself. This technology is economical, ensures consistency, and avoids the negative environmental impacts associated with traditional agriculture. BioHarvest is currently focused on nutraceuticals and the medicinal cannabis markets. Visit: www.bioharvest.com.
About Business Intelligence Group
The Business Intelligence Group was founded with the mission of recognizing true talent and superior performance in the business world. Unlike other industry award programs, business executives-those with experience and knowledge-judge the programs. The organization's proprietary and unique scoring system selectively measures performance across multiple business domains and then rewards those companies whose achievements stand above those of their peers.
For further information, please contact:
Maria Jimenez
Chief Nominations Officer
Business Intelligence Group
1 909-529-2737
jmaria@bintelligence.co
BioHarvest Sciences Inc.
Ilan Sobel, Chief Executive Officer
Dave Ryan, VP Investor Relations & Director Phone: 1 (604) 622-1186
Email: dave@bioharvest.com
Twitter: https://twitter.com/bioharvestbhsc
Facebook: https://www.facebook.com/BioHarvestSciences
LinkedIn: https://www.linkedin.com/company/bioharvestsciences/
YouTube: https://www.youtube.com/channel/UCGRJWztmLoycsLFWqwXAzAw
Forward-Looking Statements
Information set forth in this news release includes forward-looking statements that are based on management's current estimates, beliefs, intentions, and expectations, and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Investors should note that the Sustainability benchmarks cited in this release are based on industry averages for indoor cannabis cultivation as reported by New Frontiers Data reporting (to 2021) as compared to internal measurements conducted by the BioHarvest Sciences team, which have not been validated by a 3rd party.Â
All forward-looking statements are inherently uncertain and actual results may be affected by a number of material factors beyond our control. Readers should not place undue reliance on forward-looking statements. BHSC does not intend to update forward-looking statement disclosures other than through our regular management discussion and analysis disclosures.
Neither the Canadian Securities Exchange nor its Regulation Services Provider accept responsibility for the adequacy or accuracy of this release.
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/136029
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BioHarvest Sciences Inc. (CSE: BHSC) (OTCQB: CNVCF) (FSE: 8MV) ("BioHarvest" or "the Company") has announced the first multimedia campaign for VINIAâ„¢ in the USA, Phase 1. The company is scaling up its US marketing in line with a 2022 growth plan that aims for significant growth in sales orders following commercial entry in 2021.
"We are delighted to launch our first integrated marketing campaign aimed at expanding our loyal customer base here in the USA," said CEO Ilan Sobel, in New York for the launch. "Bringing our new 20 Ton production facility online was integral to scaling global VINIAâ„¢ supply, so this marketing launch is testament to the entire VINIAâ„¢ team's coordinated dedication to making it happen."
The initial phase will include TV and online advertising with a special focus on Christian programming, which includes TBN (Trinity Broadcasting Network, the world's largest religious-based television network). As part of the sponsorship agreement with TBN, Sobel will appear on the network's flagship shows hosted by Eric Metaxas and Mike Huckabee, with all content to be supported by advertising and educational online content.
New 60-second VINIAâ„¢ commercials were created specifically for the TBN campaign, to start Aug 15, 2022 (View example here)
The campaign underscores VINIA's concept of "Cellular Nutrition" and the benefits of increased blood flow, bringing in Sobel and members of his own family.
"I am inspired every day to hear from our customer community on ways that VINIAâ„¢ is improving their health," Sobel said. "We measure our success by our ability to make significant positive impact to people's lives, and as such our products' efficacy is proven not only in the clinical trials but also on a daily basis with VINIA's users."
See this link for a review of the impact on three generations of the Sobel family.
About BioHarvest Sciences Inc.
BioHarvest Sciences Inc. (CSE: BHSC) is a fast-growing Biotech firm listed on the Canadian Securities Exchange. BioHarvest has developed a patented bio-cell growth platform technology capable of growing the active and beneficial ingredients in fruit and plants, at industrial scale, without the need to grow the plant itself. This technology is economical, ensures consistency, and avoids the negative environmental impacts associated with traditional agriculture. BioHarvest is currently focused on nutraceuticals and the medicinal cannabis markets. Visit: www.bioharvest.com.
BioHarvest Sciences Inc.
Ilan Sobel, Chief Executive Officer
For further information, please contact:
Dave Ryan, VP Investor Relations & Director Phone: 1 (604) 622-1186
Email: dave@bioharvest.com
Twitter: https://twitter.com/bioharvestbhsc
Facebook: https://www.facebook.com/BioHarvestSciences
LinkedIn: https://www.linkedin.com/company/bioharvestsciences/
YouTube: https://www.youtube.com/channel/UCGRJWztmLoycsLFWqwXAzAw
Forward-Looking Statements
Information set forth in this news release includes forward-looking statements that are based on management's current estimates, beliefs, intentions, and expectations, and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. There is no assurance that strong sales metrics experienced to date will result in future demand or that proposed additional marketing expenditures will result in increased sales. There is no assurance that the company will achieve significant growth in sales orders as this would require that the marketing campaign is successful which is subject to uncertainty, particularly the response of target audiences to the campaign. Markets for nutraceuticals are unpredictable and subject to changes in consumer tastes and trends as well as economic factors beyond our control. Delays and cost overruns may result in delays achieving our objectives obtaining market acceptance, and regulatory approvals for geographic expansion are subject to risk and cannot be guaranteed.
All forward-looking statements are inherently uncertain and actual results may be affected by a number of material factors beyond our control. Readers should not place undue reliance on forward-looking statements. BHSC does not intend to update forward-looking statement disclosures other than through our regular management discussion and analysis disclosures.
Neither the Canadian Securities Exchange nor its Regulation Services Provider accept responsibility for the adequacy or accuracy of this release.
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/134209
News Provided by Newsfile via QuoteMedia
BioHarvest Sciences Inc. (CSE: BHSC) (OTCQB: CNVCF) (FSE: 8MV) ("BioHarvest" or "the Company") ") is pleased to announce that its common shares are now trading on the OTCQB® Venture Market under the ticker symbol "CNVCF".
"Admission to the OTCQB® market is an important step to increase US investor access to BioHarvest Sciences, and it provides US investors an additional level of transparency as we expand both our investor base and our customer base in North America." Stated CEO Ilan Sobel. "We will continue to work on expanding our global visibility to investors to match the commercial entry of our products into new markets."
The BioHarvest Sciences Executive team holds regular online meetings to maintain close ties with the US investment community. All interested media and investors are invited to contact info@bioharvest.com for information on the Company's next interactive event. For more detail on 2022 progress, the July 7, Q2 Shareholder Update focuses on the Company's scale-up plans in the US for its VINIA product, and the market entry strategy for the Company's cannabis products. The recording of that event is available here: https://bioharvest.com/investors/
About the OTCQB Market
The OTCQB® Venture Market is for early-stage and developing U.S. and international companies. To be eligible, companies must be current in their financial reporting and undergo an annual verification and management certification process. The OTCQB® quality standards provide a strong baseline of transparency, as well as the technology and regulation to improve the information and trading experience for investors.
Investors can find current financial disclosure and quotes for the company on https://www.otcmarkets.com/stock/CNVCF.
BioHarvest Sciences will continue to trade on the Canadian Securities Exchange (CSE) as "BHSC" and on Frankfurt as "8MV".
About BioHarvest Sciences Inc.
BioHarvest Sciences Inc. (CSE: BHSC) is a fast-growing Biotech firm listed on the Canadian Securities Exchange. BioHarvest has developed a patented bio-cell growth platform technology capable of growing the active and beneficial ingredients in fruit and plants, at industrial scale, without the need to grow the plant itself. This technology is economical, ensures consistency, and avoids the negative environmental impacts associated with traditional agriculture. BioHarvest is currently focused on nutraceuticals and the medicinal cannabis markets. Visit: www.bioharvest.com.
BioHarvest Sciences Inc.
Ilan Sobel, Chief Executive Officer
For further information, please contact:
Dave Ryan, VP Investor Relations & DirectorÂ
Phone: 1 (604) 622-1186
Email: dave@bioharvest.com
Forward-Looking Statements
Information set forth in this news release includes forward-looking statements that are based on management's current estimates, beliefs, intentions, and expectations, and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. There is no assurance that strong sales metrics experienced to date will result in future demand or that proposed additional marketing expenditures will result in increased sales. Markets for nutraceuticals are unpredictable and subject to changes in consumer tastes and trends as well as economic factors beyond our control. Delays and cost overruns may result in delays achieving our objectives obtaining market acceptance, and regulatory approvals for geographic expansion are subject to risk and cannot be guaranteed. Projected sales of BioHarvest products will require the Company to obtain production and/or export licensing which cannot be assured.
All forward-looking statements are inherently uncertain and actual results may be affected by a number of material factors beyond our control. Readers should not place undue reliance on forward-looking statements. BHSC does not intend to update forward-looking statement disclosures other than through our regular management discussion and analysis disclosures.
Neither the Canadian Securities Exchange nor its Regulation Services Provider accept responsibility for the adequacy or accuracy of this release.
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/131117
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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 Hydrationâ„¢ 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
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) Â
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 Â
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
Interstitial Lung Disease (ILD)/Pneumonitis
Most Common Adverse Reactions
Drug Interactions
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
Please see full Prescribing Information , including Boxed WARNING.
About Amgen Â
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
View original content to download multimedia: https://www.prnewswire.com/news-releases/fda-approves-lumakras-sotorasib-in-combination-with-vectibix-panitumumab-for-chemorefractory-kras-g12c-mutated-metastatic-colorectal-cancer-302354291.html
SOURCE Amgen
News Provided by PR Newswire via QuoteMedia
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) Â
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 Â
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
Interstitial Lung Disease (ILD)/Pneumonitis
Most Common Adverse Reactions
Drug Interactions
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
Please see full Prescribing Information , including Boxed WARNING.
About Amgen Â
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
View original content to download multimedia: https://www.prnewswire.com/news-releases/fda-approves-lumakras-sotorasib-in-combination-with-vectibix-panitumumab-for-chemorefractory-kras-g12c-mutated-metastatic-colorectal-cancer-302354291.html
SOURCE Amgen
News Provided by PR Newswire via QuoteMedia
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 Hydrationâ„¢. 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 Hydrationâ„¢ 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 Hydrationâ„¢ 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 Hydrationâ„¢ have been sold.
Under the agreement with Coach Chippy, Cizzle Brands will release a special-edition tropical fruit flavour of CWENCH Hydrationâ„¢ 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 Hydrationâ„¢ 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 Hydrationâ„¢ 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 Hydrationâ„¢ 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 Hydrationâ„¢. 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 Hydrationâ„¢ 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: Â
Setti Coscarella
Head of Corporate Development
investors@cizzlebrands.com
1-844-588-2088
News Provided by Business Wire via QuoteMedia
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:
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
News Provided by GlobeNewswire via QuoteMedia
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.
This Cizzle Brand Corporation profile is part of a paid investor education campaign.*
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