U. S. marijuana law enforcement may not be "proper," according to a statement written by Supreme Court Justice Clarence Thomas. The legal opinion made public Monday (June 28) was in response to a case the court was asked to consider. That case, which involved a Colorado marijuana business attempting to challenge the tax burden created by federal prohibition and 280E, is a "prime example" of the "mixed signals" coming from the federal government regarding cannabis, according to the Supreme Court justice. Read More >>
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Clarence Thomas' Statement on Half-in, Half-out Marijuana Laws
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Notice of Extraordinary General Meeting/Proxy Form
Notice is hereby given that an Extraordinary General Meeting of Shareholders of BPH Global Limited ACN 009 104 330 will be held at 3:00pm AEST on 24 May 2024 at Suite 5, Level 12, 530 Collins Street, Melbourne VIC 3000 (Meeting).
The Explanatory Statement to this Notice of Meeting provides additional information on matters to be considered at the Extraordinary General Meeting. The Explanatory Statement and the Proxy Form forms part of this Notice of Meeting.
The Directors have determined pursuant to Regulation 7.11.37 of the Corporations Regulations 2001 (Cth) that the persons eligible to vote at the Extraordinary General Meeting are those who are registered Shareholders at 7:00pm AEST on 22 May 2024.
Terms and abbreviations used in this Notice of Meeting and Explanatory Statement are defined in the Glossary.
Click here for the full ASX Release
This article includes content from BPH Global Ltd, licensed for the purpose of publishing on Investing News Australia. This article does not constitute financial product advice. It is your responsibility to perform proper due diligence before acting upon any information provided here. Please refer to our full disclaimer here.
Biotech Market Update: Q1 2024 in Review
The first quarter of 2024 witnessed a surge in initial public offerings (IPOs) and mergers and acquisitions (M&A) within the biotech industry, signaling continued interest from investors.
AstraZeneca’s acquisition of start-up Amolyt on March 14, and its longtime biotech partner Fusion Pharmaceuticals for US$2.4 billion on March 19 marked the third acquisition of a radiopharmaceutical developer in recent months. As of writing, there have been 14 M&A deals struck in 2024, according to data from Biopharma Dive.
Investment bank Jefferies released data in early March revealing that the sector was on track to earn its highest quarterly total in three years, reflecting the cautiously optimistic outlook at this year's JPM24 conference.
Two influential factors continued to shape the market landscape during this period: patent cliffs and the implementation of the Inflation Reduction Act (IRA), which have placed pressure on companies to develop new strategies and products to offset potential revenue losses.
Here the Investing News Network provides valuable coverage of the biotech industry, delivering investor-focused news and in-depth analysis of the industry’s first quarter in 2024.
Deals, patent cliffs, M&A, partnerships
With patent cliffs looming, leaders in the pharmaceutical industry turned to biotech partnerships and investments as a strategic approach. A prime example is the collaboration between J&J and Novo Holdings, who co-led a Series A funding round raising 30 million euros for Swedish biotech start-up Asgard Therapeutics. The nascent developer of in vivo treatments represents an opportunity for established pharmaceutical companies to support innovation and explore new therapeutic avenues.
“Pharma companies have now been (put) to work,” said Maha Katabi, general partner at Sofinnova Investments, while speaking at the January 10 “Biotech Funding” panel, part of the Biotech Showcase at the JP Morgan Healthcare Conference in January. “There is a great need to replenish (the) innovation pipeline. There's plenty of innovation in our sector, especially in the hands of biotech companies, and once proof of concept is achieved, that becomes a very rarefied but unique class that pharma is very interested in talking to.”
J&J’s investment in biotech startups, such as the strategic acquisition of Abiomed in 2022, exemplifies the influence the biotech industry has had on the growth and performance of established pharmaceutical companies. J&J’s Q4 2023 earnings call resulted in the company reporting increased earnings per share as it narrowly beat Wall Street expectations despite ongoing legal challenges. According to the earnings report, J&J’s acquisition of Abiomed in 2022 contributed to a 13.3 percent year-over-year revenue increase, and the company expects stable medical device equipment sales throughout 2024.
Other pharmaceutical companies have also pursued strategic acquisitions and partnerships to strengthen their positions within the market. In Q1, AbbVie agreed to acquire immune drug developer Landos for US$138 million, enhancing its presence in the immunology sector. Additionally, Pfizer's US$43 billion acquisition of Seagen in December 2023 prompted the company to focus on four types of cancer, with plans to have eight new drugs on the market by 2030.
Ahead of the 2028 patent expiration of Merck’s top-selling cancer drug, Keytruda, the company made progress in refilling its drug pipeline by acquiring cancer biotech Harpoon for US$680 million on January 8, and by obtaining approval for Winrevair, a lung disease drug acquired through the company’s 2021 buyout of biopharmaceutical company Acceleron Pharma. Merck expects that Winrevair will bring in US$35 billion in sales by 2035. The company also announced its intention to develop newer versions of its HPV vaccines, Gardasil and Gardasil 9, on March 13.
In light of these strategic moves, it’s worth noting the progress made by biosimilar developers in offering more affordable alternatives to expensive biologic drugs. Simlandi, a biosimilar to AbbVie’s Humira developed by Alvotech and Teva Pharmaceuticals, won FDA approval in February, following initial rejections due to manufacturing issues. This approval is a major achievement as Simlandi has become the first biosimilar to be designated as interchangeable with Humira, whose patent expired in January 2023.
Price Negotiations, Profits, IRA
The Centers for Medicare and Medicaid Services confirmed on January 3 that sickle cell disease would be the initial focus of a pilot program designed to improve patient access to costly cell and gene therapies.
Elsewhere, implementation of drug price negotiations under the Inflation Reduction Act (IRA) had a significant impact on the pharmaceutical and biotech industries, with several lawsuits filed by Big Pharma against the Department of Health and Human Services alleging that drug price provisions violate due process. AstraZeneca went as far as arguing that Medicaid’s authority under the IRA is unconstitutional, a claim ultimately dismissed by the U.S. District Court in Delaware.
Initial offers for 10 drugs – including Eliquis, Jardiance, Xarelto, Januvia, Farxiga, Entresto, Enbrel, Imbruvica, Stelara, as well as insulins Fiasp and NovoLog – were sent to manufacturers on February 1. Administration officials said they expect these negotiations to extend into the summer, with final prices being determined by September 1.
Pfizer has stated that concerns over the IRA are the main reason for the company’s shift to developing biologics, which are safe from price negotiations for 13 years, instead of small-molecule drugs, which only have a nine-year window. This strategic pivot speaks to the industry’s efforts to adapt to the new legislation.
Despite concerns from some experts, such as executive director of No Patient Left Behind Peter Rubin, that these provisions could have negative effects on research and development into new small-molecule drugs, companies like Madrigal demonstrated continued potential for innovation in this area in Q1. Madrigal's groundbreaking FDA approval for its MASH treatment and subsequent public offering of its common stock highlight the opportunities that still exist within the small-molecule drug landscape.
Also, AstraZeneca received FDA approval for Tagrisso, a small molecule drug to be administered alongside chemotherapy in lung cancer patients.
Research Areas: Neuro. cancer/targeted therapies/rare diseases/obesity
The field of CAR-T therapy, a promising area of cancer immunotherapy that Evaluate’s report on antibody-drug conjugates called “the hottest real estate in oncology,” has garnered significant interest from investors and regulators in recent years. J&J secured regulatory backing from the European Medicines Agency in January for earlier use of its CAR-T treatment, Carvykti, in treating multiple myeloma. The company also announced promising findings from a late-stage study on Nipocalimab, an investigational monoclonal antibody.
According to BioInformant’s 2024 CAR-T Financing Report, companies working on CAR-T therapies have attracted a total of US$6.7 billion in venture capital investment and raised US$5.76 billion through their initial public offerings (IPOs) over the past decade. EY Global Life Sciences Deals Leader Subin Baral told Pharmaceutical Technology in December 2023 that CAR-T therapies likely hold the most investment potential within personalized medicine, although he clarified that the biggest investment surge is likely a few years away, indicating the potential for long-term growth. Recently, researchers have identified use cases for CAR-T therapy to treat lupus.
Despite its promise, 25 recent reports of rare blood cancers in patients who had gotten CAR-T therapy prompted the FDA to order drugmakers to add a warning of such risks to their packaging. Nevertheless, FDA spokesperson Carly Kempler told NBC News that “the overall benefits of these products continue to outweigh their potential risks.”
Subin also mentioned to INN in the Biotech Market Outlook Report that he expects more exploration of other therapies in the short term, such as antibody-drug conjugates (ADCs). ADCs feature an antibody linked to a cytotoxic payload, which is released when the ADC binds to its target.
Astra Zeneca won the approval of the "tumor agnostic" ADC Enhertu, which was developed in partnership with Daiichi Sankyo, and Gilead secured funding from life sciences investment firm Abingworth for a new trial of its ADC Trodelvy, Gilead also partnered with Dutch biotech company Merus to research and develop new tri-specific antibodies for cancer treatment.
Several pharmaceutical companies also focused on the weight loss drug market this quarter. Roche decided to discontinue eight drug candidates to concentrate on obesity treatments, and Viking Therapeutics, a small biotech firm, has doubled its shares after reporting promising results in mid-stage trials for its obesity drug VK2735. Zealand Pharma has also reported positive results for survodutide, which could be a potential obesity treatment.
Novo Holdings, the controlling shareholder of Novo Nordisk, purchased global contract development and manufacturing organization Catalent for US$16.5 billion on February 15, an acquisition that enables increased production of its blockbuster drugs Ozempic and Wegovy by taking over operations at three plants in Italy. In a significant development, Medicare announced on March 22 that it will now cover Wegovy under Part D plans for select patients with a history of heart disease.
Novo Nordisk also announced promising results from a study of its latest obesity treatment, amycretin. The biologic drug demonstrated an average weight loss of 13.1 percent in 12 weeks, surpassing Wegovy’s 6 percent average. Following the news, Novo Nordisk shares surged 8.3 percent in Copenhagen on March 7.
Similarly, Eli Lilly’s biologic diabetes drug Mounjaro generated over US$5 billion in sales, driving a 20 percent revenue increase compared to 2022. The strong financial performance of both companies has led analysts to predict they could become healthcare’s first trillion-dollar companies.
Trends that might impact the market
Looking ahead to Q2, pharma and biotech editor at WTWH Media Brian Buntz anticipates increased stability in the biotech sector, citing a time-series analysis of the NASDAQ Biotech Index. In addition, several crucial FDA approvals are anticipated between April and June that may affect the pharmaceutical and biotech landscapes.
These include potential expanded approvals for CAR-T therapies and Pfizer’s gene therapy for hemophilia B. Alnylam, on the other hand, encountered challenges as the data readout of its heart disease drug HELIOS-B was pushed to June or July, leading to falling shares and raising concerns about the drug’s efficacy.
In the field of neurological disorders, some promising developments emerged during this period, potentially influencing market trends in the healthcare industry.
Recent research has revealed that focused ultrasound could enhance the plaque-clearing effects of Aduhelm, an anti-amyloid-beta monoclonal antibody drug developed by Biogen and Eisai that has shown difficulty penetrating the blood-brain barrier. This discovery may lead to more effective treatment options for patients with Alzheimer’s disease and other neurological conditions.
Various promising drugs for schizophrenia are currently in different stages of development. Karuna’s KarXT, designed to minimize side effects while maximizing therapeutic effects by targeting a different brain chemical than traditional treatments, is expected to receive an FDA decision in September. Other contenders in the race for FDA approval include Cerevel, which AbbVie plans to acquire by mid-2024, and Nuplazid by Acadia, already approved for psychosis in Parkinson’s disease.
Finally, Novo Nordisk announced its intention to purchase RNA drug developer Cardior, along with its mid-stage treatment CDR132L. Results from that trial are expected in September and could influence the company’s market position and the broad landscape of RNA-based therapeutics.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.
AMGEN TO PRESENT TEZSPIRE® PHASE 2A COPD DATA AT ATS 2024
Planning Underway for Phase 3 Development of Tezepelumab in COPD
Amgen (NASDAQ:AMGN) today provided an update regarding the results of the Phase 2a COURSE trial for TEZSPIRE ® (tezepelumab-ekko) in chronic obstructive pulmonary disease (COPD), which were accepted for presentation in the Clinical Trials Symposium at The American Thoracic Society (ATS) 2024 International Conference on Monday, May 20 from 9:15-11:15 a.m. PDT .
We are encouraged by the results of the COURSE Phase 2a proof-of-concept trial, which investigated tezepelumab in moderate to very severe COPD patients, across a broad range of eosinophil levels, irrespective of inflammatory drivers, emphysema, chronic bronchitis and smoking status. This study did not exclude any patients based on their baseline eosinophil count (BEC) and intentionally enrolled patients with a broad range of BECs. Overall, tezepelumab numerically reduced the annualized rate of moderate or severe COPD exacerbations versus placebo by 17% (90% CI: −6, 36; p=0.1042). Of note, more reductions were observed in a prespecified subgroup of patients with BEC ≥150 cells/μL (37% [95% CI: 7, 57]). The trend in reduction was greater in a small number of subjects with BEC ≥300 cells/µL.
"We are excited by these data and optimistic about the potential tezepelumab has for patients with COPD, a condition that continues to have a significant unmet medical need," said James Bradner , M.D., executive vice president of Research and Development and chief scientific officer at Amgen.
We look forward to presenting the full data set at the congress and based on these findings, we are actively planning for the Phase 3 development of tezepelumab in COPD.
TEZSPIRE is a registered trademark of Amgen Inc. and AstraZeneca.
TEZSPIRE ® (tezepelumab-ekko) U.S. Indication
TEZSPIRE is indicated for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma.
TEZSPIRE is not indicated for the relief of acute bronchospasm or status asthmaticus.
TEZSPIRE ® (tezepelumab-ekko) Important Safety Information
CONTRAINDICATIONS
Known hypersensitivity to tezepelumab-ekko or excipients.
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions
Hypersensitivity reactions were observed in the clinical trials (e.g., rash and allergic conjunctivitis) following the administration of TEZSPIRE. Postmarketing cases of anaphylaxis have been reported. These reactions can occur within hours of administration, but in some instances have a delayed onset (i.e., days). In the event of a hypersensitivity reaction, consider the benefits and risks for the individual patient to determine whether to continue or discontinue treatment with TEZSPIRE.
Acute Asthma Symptoms or Deteriorating Disease
TEZSPIRE should not be used to treat acute asthma symptoms, acute exacerbations, acute bronchospasm, or status asthmaticus.
Abrupt Reduction of Corticosteroid Dosage
Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of therapy with TEZSPIRE. Reductions in corticosteroid dose, if appropriate, should be gradual and performed under the direct supervision of a physician. Reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy.
Parasitic (Helminth) Infection
It is unknown if TEZSPIRE will influence a patient's response against helminth infections. Treat patients with pre-existing helminth infections before initiating therapy with TEZSPIRE. If patients become infected while receiving TEZSPIRE and do not respond to anti-helminth treatment, discontinue TEZSPIRE until infection resolves.
Live Attenuated Vaccines
The concomitant use of TEZSPIRE and live attenuated vaccines has not been evaluated. The use of live attenuated vaccines should be avoided in patients receiving TEZSPIRE.
ADVERSE REACTIONS
The most common adverse reactions (incidence ≥3%) are pharyngitis, arthralgia, and back pain.
USE IN SPECIFIC POPULATIONS
There are no available data on TEZSPIRE use in pregnant women to evaluate for any drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Placental transfer of monoclonal antibodies such as tezepelumab-ekko is greater during the third trimester of pregnancy; therefore, potential effects on a fetus are likely to be greater during the third trimester of pregnancy.
Please see the full Prescribing Information including Patient Information and Instructions for Use .
About Amgen
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
Amgen is one of the 30 companies that comprise the Dow Jones Industrial Average and is also part of the Nasdaq-100 index. In 2023, Amgen was named one of "America's Greatest Workplaces" by Newsweek, one of "America's Climate Leaders" by USA Today and one of the "World's Best Companies" by TIME.
For more information, visit Amgen.com and follow us on X (formerly known as Twitter), LinkedIn , Instagram , TikTok , YouTube and Threads .
Amgen Forward-Looking Statements
This communication 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. 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 communication 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.
Any scientific information discussed in this release relating to new indications for Amgen's products is preliminary and investigative and is not part of the labeling approved by the U.S. Food and Drug Administration for the products. The products are not approved for the investigational use(s) discussed in this release, and no conclusions can or should be drawn regarding the safety or effectiveness of the products for these uses.
CONTACT: Amgen, Thousand Oaks
Jessica Akopyan , 805-440-5721 (media)
Justin Claeys , 805-313-9775 (investors)
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SOURCE Amgen
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Biotech Stocks: 5 Biggest Companies in 2024
What are the top biotech companies? The following five stocks have market capitalizations worth billions of dollars and operate in countries all around the globe.
Plus, these big-name biotech players have pipelines stuffed with potentially disruptive products — and enough revenue to recover should some of those products fail.
This means that investors can experience the excitement of biotech investing while minimizing risk. Although returns are never guaranteed, company size can insulate investors from volatility.
Which biotech companies should investors consider?
If you’re cautiously interested in biotech stocks, starting with the top companies by market cap could be a good strategy. This list of the largest NASDAQ biotech stocks was compiled using Investing.com’s stock screener, and all numbers were current as of April 2, 2024. NYSE biotech stocks were considered as well, but did not make the cut.
1. Vertex Pharmaceuticals (NASDAQ:VRTX)
Market capitalization: US$105.58 billion
Vertex Pharmaceuticals is a global biotech firm focused on developing and commercializing therapies for treating cystic fibrosis. It has a number of approved treatments for cystic fibrosis, and a pipeline of genetic and cell therapies for diseases such as sickle cell disease, beta thalassemia, Duchenne muscular dystrophy and type 1 diabetes.
Vertex announced in March 2024 that the US Food and Drug Administration (FDA) has cleared an Investigational New Drug Application for its drug candidate VX-407, which targets the underlying cause of the most common inherited kidney disease, autosomal dominant polycystic kidney disease, in patients with a subset of PKD1 genetic variants.
2. Regeneron Pharmaceuticals (NASDAQ:REGN)
Market capitalization: US$102.47 billion
Biotech leader Regeneron Pharmaceuticals develops and commercializes medicines targeting cancer, pain and a wide variety of diseases, including inflammatory, cardiovascular, metabolic, hematologic and rare diseases.
The FDA has approved nine of the treatments in the company’s portfolio, and the company also has a number of product candidates in development. Its Regeneron Genetics Center is investigating approaches to speeding up the discovery and development of medicines for serious illnesses.
The company's announced in March that an extension for its Praluent treatment for heterozygous familial hypercholesterolemia, an inherited genetic disorder that leads to extremely high levels of cholesterol and associated health risks, has been approved by the FDA for pediatric patients aged 8 and older in combination with diet and other low-density lipoprotein cholesterol (LDL-C) lowering therapies.
3. Moderna (NASDAQ:MRNA)
Market capitalization: US$39.97 billion
Best known today for the rapid deployment of effective COVID-19 vaccines, Moderna leads the world in the field of mRNA-based medicine. Alongside a diverse clinical and intellectual property portfolio targeting infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases, the company’s assets include an integrated manufacturing plant that allows for both clinical and commercial production.
In April 2023, the biotechnology and pharmaceutical company partnered with technology giant IBM (NYSE:IBM) to explore the use of quantum computing and generative artificial intelligence in developing mRNA medicines.
Moderna completed the construction of its state-of-the art mRNA manufacturing facility in Laval, Québec, Canada, in February of this year. Beginning in 2025, pending regulatory approvals, the facility is expected to manufacture respiratory mRNA vaccines for Canadians.
“The construction of this facility marks an important milestone in Moderna’s strategic partnership with the federal government to support domestic preparedness for future pandemics for all Canadians,” the press release stated.
4. Argenx (NASDAQ:ARGX)
Market capitalization: US$23.1 billion
Belgian global immunology company Argenx is developing an extensive pipeline of novel antibody-based medicines for the treatment of patients with severe autoimmune diseases.
The company’s portfolio includes commercial drug product Vyvgart, which is indicated for the treatment of the neuromuscular disease generalized myasthenia gravis in adult patients. The treatment uses IgG antibodies, a protein made by the immune system.
In late March 2024, Argenx announced that Vyvgart had obtained approval in Japan for its use as an intravenous treatment in adults with primary immune thrombocytopenia.
5. BioNTech (NASDAQ:BNTX)
Market capitalization: US$21.81 billion
Biopharmaceutical firm BioNTech is advancing immunotherapies for serious diseases such as cancer. The company’s portfolio of oncology product candidates includes mRNA-based therapies, CAR-T cell therapies and targeted cancer antibodies. In partnership with Pfizer (NYSE:PFE), BioNTech brought to market one of the world’s most important COVID-19 vaccines.
Last year, BioNTech inked a potential US$1.67 billion collaboration deal with China-based biotech company Duality Biologics. Under the agreement, BioNTech received licensing rights outside of China, Hong Kong and Macau to develop, manufacture and license two of Duality Biologics' antibody-drug conjugate candidates targeting solid tumors.
This January, the partner companies announced that the FDA granted Fast Track designation for the use of the candidate BNT325/DB-1305 for the treatment of platinum-resistant ovarian epithelial cancer, fallopian tube cancer or primary peritoneal cancer in patients who have previously received one to three systemic treatment regimens.
This is an updated version of an article originally published by the Investing News Network in 2016.
Don’t forget to follow us @INN_LifeScience for real-time news updates!
Securities Disclosure: I, Melissa Pistilli, hold no direct investment interest in any company mentioned in this article.
SIRONA BIOCHEM Corporate Update April 2024
Sirona Biochem Corp . (TSX-V: SBM) (FSE: ZSB) (OTC: SRBCF) (" Sirona " or the " Company ") provides the following update:
Dear shareholders,
We are pleased to provide an update on our recent milestones and strategic decisions shaping Sirona Biochem's path forward.
AGM
Last week, during our Annual General Meeting (AGM), we successfully gained another year of backing for our management team. Although it's common for many shareholders to abstain from voting, we're pleased to report that we've received numerous messages from our shareholders expressing their support for our ongoing corporate strategy.
Financing
We have closed our financing well below its anticipated goal. The small cap marketplace in the Canadian market is very challenged at this time. Our past supporting brokers do not have the fund-raising capabilities of the past. Instead of dropping the financing share price we are in discussion with investment funds to assist with our financial needs. This includes funds based in Europe, North America, and Asia, linking future investments to our commercialization of GlycoProteMim TM .
The commercialization of GlycoProteMim TM offers substantial potential for financial returns, benefits from clinically validated technology, and has a relatively swift path to generating revenue.
We persist in exploring non-dilutive funding sources from France and Canada as our preferred financing option whenever feasible.
Branding of GlycoProteMim TM (TFC-1326)
We have successfully selected the brand name for our anti-aging product. We will soon be proceeding with the formal trademark registration. The name will be made public closer to launch. Our cosmetic branding expert, based in Paris, is currently concentrating on developing brand messaging to establish this new product line as a premium offering in the anti-aging market.
Preparation for Commercialization of GlycoProteMim TM
We are on track for a commercial launch of our first consumer products containing GlycoProteMim TM in Europe and North America in early 2025 through our subsidiary, Sirona Laboratories, with plans to expand to other international markets afterward. Additionally, we've expanded our strategy to include the development of a second GlycoProteMim TM -infused product. Our brand and marketing team is convinced that broadening our product range is essential for achieving the best market penetration and ensuring consumer satisfaction.
An initial production batch of custom cosmetic containers, tailor-made for our products, is currently being manufactured by a premier French company. We have engaged a South Korean specialist in product label design to create our labels. Furthermore, a renowned Parisian facialist is crafting a specific massage protocol for the application of our products.
Product Samples
The demand for product samples has arisen earlier in the development phase than expected, prompting us to adjust our plans to accommodate this interest. It's clear that people are eager to physically interact with the product themselves. At this point, our capability to provide samples is limited to key potential stakeholders around the world who require a hands-on experience with the product to build their investment confidence.
Overall GlycoProteMim TM Strategy
Our strategy involves launching in Europe and North America in early 2025, with a view to exploring licensing opportunities in pivotal markets such as South Korea, Japan, and China, where partnering is the favored approach for market entry. We foresee a variety of commercialization paths. Possessing established products significantly enhances our ability to achieve this objective. Key contacts have been pinpointed, and we are in the process of identifying additional ones.
Our strategy does not encompass any solitary licensing agreement. Our patent application for GlycoProteMim TM spans 54 countries, encompassing all major markets.
Pipeline
Sirona Biochem is currently honing its focus on the cosmetic and therapeutic skincare sector, where we identify the most significant commercial potential. Our pipeline includes a variety of projects, some of which have been made public, while others are kept under wraps due to competitive reasons and intellectual property concerns. Our scientific team is continuously at the forefront of innovation, discovering incredibly promising opportunities.
TFC-1067 Global License Agreement
Allergan Aesthetics is actively progressing with the integration of TFC-1067 into its product lineup. We will inform our shareholders of any developments as soon as it is feasible. The introduction of TFC-1067 into the market presents a significant chance to enhance our company's value and expand our growth prospects. It's important for shareholders to recognize that this is a global licensing agreement, which represents a considerably greater value to Sirona compared to the prior supply agreement with Rodan and Fields.
Summary
Navigating the financial challenges in this market is complex, but we have strategies in place to address them. While there are concerns among shareholders about dilution, our plans carry substantial potential to benefit our shareholders significantly. Although some level of dilution may occur, our goal is to enhance value to a degree that more than validates our approach. The continued support from our shareholders is crucial for our collective success.
About Sirona Biochem Corp.
Sirona Biochem is a biotechnology company focussing on innovative cosmetic and dermatology active ingredients 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 .
For more information regarding this press release, please contact:
Investor Enquiries:
Christopher Hopton
Chief Financial Officer
Phone: (604) 641-4466
Email: info@sironabiochem.com
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
Forward Looking Statements
This news release includes certain statements that may be deemed "forward-looking statements". All statements in this new 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.
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Sirona Biochem Announces Close of Private Placement
Vancouver, British Columbia – April 4, 2024 Sirona Biochem Corp . (TSX-V: SBM) (Frankfurt: ZSB) (" Sirona ") has closed its private placement (Private Placement") for gross proceeds of $132,500 CAD. The Private Placement consists of 1,325,000 units, (the "Units") at a price of $0.10 per Unit. Each Unit consists of one common share and one transferable share purchase warrant, each whole warrant exercisable into one additional common share of the Company for a period of 2 years from the date of issue at a price of $0.15 per Share in year one and $0.25 per Share in year two. All securities issued under the Private Placement are subject to statutory hold periods expiring on August 4, 2024.
Proceeds will be used for general working capital purposes.
No insiders participated in the Private Placement.
No finders' fees were paid from the Private Placement.
About Sirona Biochem Corp.
Sirona Biochem 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 located 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 .
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
For more information regarding this press release, please contact:
Christopher Hopton, CFO,
604-641-4466
Email: Info@sironabiochem.com
Sirona Biochem cautions you that statements included in this press release that are not a description of historical facts may be forward-looking statements. Forward-looking statements are only predictions based upon current expectations and involve known and unknown risks and uncertainties. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of release of the relevant information, unless explicitly stated otherwise. Actual results, performance or achievement could differ materially from those expressed in, or implied by, Sirona Biochem's forward-looking statements due to the risks and uncertainties inherent in Sirona Biochem's business including, without limitation, statements about: the progress and timing of its clinical trials; difficulties or delays in development, testing, obtaining regulatory approval, producing and marketing its products; unexpected adverse side effects or inadequate therapeutic efficacy of its products that could delay or prevent product development or commercialization; the scope and validity of patent protection for its products; competition from other pharmaceutical or biotechnology companies; and its ability to obtain additional financing to support its operations. Sirona Biochem does not assume any obligation to update any forward-looking statements except as required by law.
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