Welcome to our dedicated page for BIONTECH news (Ticker: BNTX), a resource for investors and traders seeking the latest updates and insights on BIONTECH stock.
BioNTech SE (NASDAQ: BNTX) generates frequent news flow as a global next generation immunotherapy company focused on oncology, mRNA technologies and COVID-19 vaccines. Its updates often cover progress across a diversified oncology pipeline that includes mRNA cancer immunotherapies, next-generation immunomodulators, antibody-drug conjugates (ADCs) and chimeric antigen receptor (CAR) T cell therapies, as well as developments in its mRNA vaccine programs for infectious diseases.
Investors following BioNTech news can expect regular announcements on clinical trial milestones in major tumor types such as lung, breast, gynecologic, gastrointestinal and genitourinary cancers. Recent releases have highlighted late-stage data readouts and trial initiations for investigational agents like pumitamig (a PD-L1xVEGF-A bispecific antibody co-developed with Bristol Myers Squibb) and gotistobart (a CTLA-4–targeting Treg modulator), including Phase 2 and Phase 3 results in indications such as triple-negative breast cancer and squamous non-small cell lung cancer.
BioNTech’s news stream also includes corporate and financial updates, such as quarterly results, guidance changes, and details of its cash and investment position. The company reports on its COVID-19 vaccine franchise, including launches of variant-adapted vaccines for specific vaccination seasons, and comments on how vaccine market dynamics affect revenues.
Another recurring theme in BNTX news is strategic transactions and partnerships. BioNTech has announced an all-stock acquisition of CureVac N.V. to strengthen its position in mRNA design, delivery formulations and manufacturing, and regularly issues releases on its collaboration with partners including Bristol Myers Squibb, Duality Biologics, OncoC4, Pfizer and others.
This news page aggregates these developments in one place, allowing readers to track BioNTech’s clinical progress, partnership activity, financial disclosures and strategic updates over time.
Pfizer and BioNTech announced the U.S. government's purchase of an additional 50 million COVID-19 vaccine doses, bringing the total to 600 million under the existing supply agreement. This move supports pediatric vaccination efforts, particularly for children under 5, pending regulatory authorization. Deliveries are anticipated by April 30, 2022. Furthermore, the companies aim to manufacture 4 billion doses worldwide in 2022, with a commitment to provide vaccines to low-income countries. The FDA has been approached for Emergency Use Authorization for children aged 5 to under 12 years.
BioNTech SE (Nasdaq: BNTX) will announce its Q3 2021 financial results on November 9, 2021. A conference call and webcast for investors and analysts will be held at 8:00 a.m. ET (2:00 p.m. CET) the same day. Participants can access the presentation and audio via a provided link and will receive conference call details, including dial-in numbers and Conference ID. BioNTech continues to focus on immunotherapy development, having established partnerships with major pharmaceutical companies like Pfizer, Sanofi, and Bayer. Further information is available on their website.
Pfizer and BioNTech announced FDA's Vaccines Advisory Committee voted 17-0, with 1 abstention, to recommend Emergency Use Authorization (EUA) for their COVID-19 vaccine for children aged 5 to <12 years. This vaccine demonstrated a 90.7% efficacy rate in clinical trials conducted during the Delta variant surge, using a 10-µg dosage. If authorized, this will be the first COVID-19 vaccine approved for this age group in the U.S. The companies anticipate starting vaccine distribution immediately upon authorization, ensuring free access for eligible children.
Pfizer and BioNTech announced that the FDA advisory committee voted 17-0, with 1 abstention, to recommend Emergency Use Authorization for their COVID-19 vaccine in children aged 5 to <12 years. The clinical trial data showed a favorable safety profile and a high efficacy rate of 90.7% against COVID-19 during the Delta variant prevalence. The vaccine, to be administered as a two-dose regimen of 10-µg doses, could be the first authorized for this age group in the U.S. If approved, pediatric vaccine doses are expected to ship immediately, maintaining free access for eligible residents.
BioNTech has signed a Memorandum of Understanding with the Rwandan Government and Institut Pasteur de Dakar to construct Africa's first mRNA vaccine manufacturing facility, beginning in mid-2022. This facility aims to create a decentralized manufacturing network capable of producing hundreds of millions of mRNA vaccine doses annually. BioNTech plans to staff and operate the facility initially while transferring operational responsibilities to local partners. The project is expected to enhance vaccine access and build local capacity in Africa.
Pfizer and BioNTech announced results from a Phase 3 randomized trial for their COVID-19 vaccine booster, demonstrating a relative vaccine efficacy of 95.6% against disease during a period dominated by the Delta variant. The trial involved over 10,000 participants aged 16 and older, showing a favorable safety profile. The companies plan to submit these findings to the FDA, EMA, and other regulators to support licensure in the U.S. and abroad, highlighting the importance of booster shots in combating COVID-19.
Pfizer and BioNTech have announced the first results from a Phase 3 trial for a COVID-19 vaccine booster, revealing a relative efficacy of 95.6% against disease during Delta's prevalence. The trial included over 10,000 participants aged 16 and older, showing the booster restored vaccine protection to levels seen after the initial two doses and had a favorable safety profile. The companies plan to submit these results to regulatory agencies for licensure in the U.S. and globally.
BioNTech (Nasdaq: BNTX) and Pfizer announced on October 4, 2021, that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for the COVID-19 vaccine's booster dose for individuals 18 and older. The decision awaits the European Commission's final approval, expected soon. Clinical trial data demonstrated that the booster dose significantly increased neutralizing antibodies against various SARS-CoV-2 variants. The companies assure existing supply agreements for the vaccine, including boosters, remain unaffected.
BioNTech (BNTX) announced its participation in the 36th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) from November 10-14, 2021, showcasing its diverse oncology pipeline. The company will present six posters and one presentation, including first-in-human data across multiple programs. CMO Dr. Özlem Türeci emphasized the progress in their oncology portfolio, highlighting efforts to advance cancer immunotherapy. Key presentations will include data on multiple innovative therapies and their clinical activities in various cancers.
Genmab A/S (NASDAQ: GMAB) announced multiple presentations at the Society for Immunotherapy of Cancer’s 36th Annual Meeting (SITC 2021), held November 10-14 in Washington, DC. The highlights include a mini-oral presentation of the first-in-human trial for DuoBody®-CD40×4-1BB (GEN1042) and a poster on DuoBody®-PD-L1×4-1BB (GEN1046). Both investigational bispecific antibodies are co-developed with BioNTech (NASDAQ: BNTX). Genmab emphasizes its commitment to advancing cancer treatment through these innovative therapies.
FAQ
What is the current stock price of BIONTECH (BNTX)?
What is the market cap of BIONTECH (BNTX)?
