About BioNTech SE - American Depositary Shares (BNTX)
BioNTech SE is a biotechnology company focused on developing and providing transformative therapies for patients suffering from serious diseases. It is primarily known for its pioneering work in mRNA-based vaccines, particularly in the field of infectious diseases and cancer immunotherapy. By leveraging its proprietary technology platform, BioNTech aims to create personalized and innovative treatments that harness the body’s natural immune response. The company is committed to advancing scientific research and bringing novel therapeutics to market, working collaboratively with partners in the pharmaceutical industry and academic institutions to address unmet medical needs globally. Read More
MAINZ, Germany, and PRINCETON, USA, September 8, 2025 – BioNTech SE (Nasdaq: BNTX, “BioNTech”) and Bristol Myers Squibb Company (NYSE: BMY, “BMS”) today presented interim data from a global randomized Phase 2 trial (NCT06449209) evaluating pumitamig (also known as BNT327 or BMS986545), an investigational bispecific antibody targeting PD-L1 x VEGF-A, plus chemotherapy in patients with extensive-stage small cell lung cancer (“ES-SCLC”). The data, which are consistent with data presented at the European Lung Cancer Congress (“ELCC”) 2025 from a Phase 2 trial conducted in China (NCT05844150), showed encouraging anti-tumor responses with a positive trend in the secondary endpoint progression free survival. Pumitamig plus chemotherapy demonstrated a manageable safety profile with no new safety signals and a low discontinuation rate. The data are being presented today as a late-breaker oral presentation at the IASLC 2025 World Conference on Lung Cancer (“WCLC”) hosted by the International Association for the Study of Lung Cancer in Barcelona.
Pfizer Inc. (NYSE: PFE, “Pfizer”) and BioNTech SE (Nasdaq: BNTX, “BioNTech”) today announced positive topline results from an ongoing Phase 3 clinical trial cohort evaluating the safety, tolerability, and immunogenicity of a 30-µg dose of the LP.8.1-adapted monovalent COMIRNATY® (COVID-19 Vaccine, mRNA) 2025-2026 Formula in adults aged 65 and older and in adults aged 18 through 64 with at least one underlying risk condition for severe COVID-19. The preliminary data show a robust increase in neutralizing antibodies targeting the LP.8.1 sublineage of SARS-CoV-2 following vaccination. These clinical findings reinforce pre-clinical data that supported the recent U.S. Food and Drug Administration (FDA) approval of the LP.8.1-adapted COVID-19 vaccine, which demonstrated improved immune responses against multiple circulating SARS-CoV-2 sublineages.
FDA approves Pfizer, Moderna, and Novavax Covid vaccines for high-risk groups as emergency authorizations end and vaccines transition to full marketing.
Pfizer Inc. (NYSE: PFE, “Pfizer”) and BioNTech SE (Nasdaq: BNTX, “BioNTech”) today announced the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for the companies’ LP.8.1-adapted monovalent COVID-19 vaccine (COMIRNATY® LP.8.1; COVID-19 Vaccine, mRNA) for use in adults ages 65 years and older, as well as in individuals ages 5 through 64 years with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.2
NEW YORK and MAINZ, GERMANY, AUGUST 27, 2025 — Pfizer Inc. (NYSE: PFE, “Pfizer”) and BioNTech SE (Nasdaq: BNTX, “BioNTech”) today announced the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for the companies’ LP.8.1-adapted monovalent COVID-19 vaccine (COMIRNATY® LP.8.1; COVID-19 Vaccine, mRNA) for use in adults ages 65 years and older, as well as in individuals ages 5 through 64 years with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.2
The Trump administration may remove COVID-19 vaccines from the U.S. market as RFK Jr.'s allies gain influence at HHS, with a new vaccine task force led by a known skeptic.
