BioNTech SE American Depositary Share - BNTX STOCK NEWS

BioNTech (Nasdaq: BNTX) and Pfizer announced a positive opinion from the European Medicines Agency's CHMP, recommending the use of their COVID-19 vaccine, COMIRNATY, for children aged 5 to under 12. This marks a significant step as it could be the first vaccine authorized in the EU for this age group. The recommendation is based on a Phase 2/3 trial involving approximately 4,500 children, showing a 90.7% efficacy rate in those without prior infection. A final decision from the European Commission is expected soon, impacting all EU member states.

The Pfizer-BioNTech COVID-19 vaccine has shown a remarkable 100% efficacy against COVID-19 in a longer-term analysis involving adolescents aged 12 to 15. The pivotal Phase 3 trial data indicated no serious safety concerns, reinforcing confidence in the vaccine's effectiveness and safety profile. The companies plan to utilize these findings to support full regulatory approval in the U.S. and globally, moving towards a supplemental Biologics License Application to expand approval for this age group. This analysis contributes substantially to the existing data supporting the continued use of the vaccine.

The Pfizer-BioNTech COVID-19 vaccine showed 100% efficacy in a longer-term analysis for adolescents aged 12-15, with no serious safety issues reported. This data supports submissions for full regulatory approval in the U.S. and globally. The analysis, part of a pivotal Phase 3 trial, indicated that 0 symptomatic COVID-19 cases occurred in vaccinated participants compared to 30 in the placebo group. The companies plan to submit this data for regulatory review to expand the vaccine's approval.

Pfizer (NYSE: PFE) and BioNTech (NASDAQ: BNTX) have received expanded FDA emergency use authorization for the COVID-19 booster dose for individuals 18 and older. The booster, to be administered at least six months post-primary series, aims to sustain high protection against COVID-19 variants, including Delta. Clinical trials indicated a vaccine efficacy of 95% for booster recipients. The companies expect no impact on existing supply agreements. The FDA's decision is crucial as the pandemic continues to evolve.

BioNTech (BNTX) and Pfizer announced an expanded emergency use authorization (EUA) for their COVID-19 vaccine booster shot in the U.S. for individuals 18 and older. Administered at least six months after the primary series, the booster shows a 95% efficacy based on recent trials. Both companies continue to supply the vaccine under existing agreements with the U.S. government, expected to last through April 2022. This authorization follows positive clinical data demonstrating robust immune responses post-booster, which may help maintain protection against variants like Delta.

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.