BIONTECH Stock Price, News & Analysis

BioNTech (Nasdaq: BNTX) announced that the FDA granted Fast Track Designation for BNT111, an investigational cancer immunotherapy targeting advanced melanoma. BNT111 is based on BioNTech's FixVac platform and aims to enhance immune responses against cancer. The ongoing Phase 2 trial explores BNT111 in combination with Libtayo for patients with therapy-resistant melanoma. This designation aims to expedite the drug’s development, highlighting its potential to meet significant medical needs.

BioNTech reported a remarkable surge in revenue, reaching €6.1 billion for Q3 2021, compared to just €67.5 million in Q3 2020. Total revenues for the first nine months of 2021 soared to €13.4 billion against €136.9 million in 2020. Key advancements include the FDA's approval of BNT162b2 for children aged 5-11 and the initiation of a Phase 2 trial for autogene cevumeran in colorectal cancer. The company anticipates total revenues of €16-17 billion for 2021, driven by vaccine demand, while maintaining R&D expenses between €950 million to €1.05 billion.

BioNTech SE (Nasdaq: BNTX) announced the presentation of new clinical data from its Phase 1/2 trial for BNT211, a CAR-T cell therapy targeting Claudin 6, at the 36th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) from November 10-14, 2021. This first-in-human study aims to evaluate the safety and efficacy of BNT211 as a monotherapy and in combination with an mRNA-based vaccine. The late-breaking abstract presentation highlights BioNTech's commitment to advancing novel cancer treatments.

The FDA has granted Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine for children aged 5 to 11 years, based on a clinical study showing a vaccine efficacy of 90.7% during the Delta variant period. This makes it the only COVID-19 vaccine approved for this age group in the U.S. The companies will begin shipping pediatric doses immediately, aiming to protect millions of children as they return to school. The CDC's Advisory Committee will soon meet to discuss vaccination recommendations, with pediatric vaccinations expected to start following CDC endorsement.

The U.S. FDA has granted Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine for children aged 5 to 11 years. This milestone is supported by clinical data indicating a 90.7% vaccine efficacy among participants when Delta was the prevalent strain. The vaccine demonstrates a favorable safety profile and will be administered in two 10-µg doses. With this authorization, Pfizer-BioNTech's vaccine is now the only option for this age group in the U.S., aiming to protect millions of school-aged children from COVID-19.

Pfizer and BioNTech announce the U.S. government's purchase of 50 million additional COVID-19 vaccine doses, bringing the total under their agreement to 600 million. This aims to support pediatric vaccinations, particularly for children under 5, pending regulatory authorization. The companies plan to deliver the doses by April 2022 and have committed to providing 1 billion doses to low and lower-middle-income countries at not-for-profit prices. Pfizer and BioNTech have already distributed over 1.8 billion doses globally, reflecting their commitment to equitable vaccine access.

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.