Tag: Duality Biologics

Conference call and webcast scheduled for August 4, 2025, at 8:00 a.m. EDT (2:00 p.m. CEST)

NEW YORK and MAINZ, GERMANY, July 25, 2025 — Pfizer Inc. (NYSE: PFE, “Pfizer”) and BioNTech SE (Nasdaq: BNTX, “BioNTech”) announced today that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorization for the companies’ LP.8.1-adapted monovalent COVID-19 vaccine (COMIRNATY^® LP.8.1) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older. The adaptation is based on the recommendation from the EMA’s Emergency Task Force (ETF) to update COVID-19 vaccines to target the LP.8.1 variant for the 2025-2026 season. The ETF stated that “targeting LP.8.1 will help maintain the effectiveness of the vaccines as SARS-CoV-2 continues to evolve.”²

NEW YORK und MAINZ, Deutschland, 25. Juli 2025 — Pfizer Inc. (NYSE: PFE, „Pfizer“) und BioNTech SE (Nasdaq: BNTX, „BioNTech“) gaben heute bekannt, dass der Ausschuss für Humanarzneimittel (Committee for Medicinal Products for Human Use, „CHMP“) der Europäischen Arzneimittel-Agentur (European Medicines Agency, „EMA“) eine positive Beurteilung für die Marktzulassung (Marketing Authorization) des an LP.8.1 angepassten monovalenten COVID-19-Impfstoffs (COMIRNATY^® LP.8.1) der Unternehmen für die aktive Immunisierung zur Vorbeugung von COVID-19 verursacht durch SARS-CoV-2 bei Personen ab 6 Monaten ausgesprochen hat. Die Anpassung basiert auf der Empfehlung der Notfall-Taskforce (Emergency Task Force, „ETF“) der EMA, die vorschlägt, COVID-19-Impfstoffe zu aktualisieren, um die LP.8.1-Variante für die Impfkampagne 2025-2026 abzudecken. Die Notfall-Taskforce erklärte: „Eine Anpassung an LP.8.1 wird dabei helfen, die Wirksamkeit der Impfstoffe gegen das sich fortlaufend weiterentwickelnde SARS-CoV-2 aufrechtzuerhalten.“² 

MAINZ and TÜBINGEN, Germany, June 12, 2025 (GLOBE NEWSWIRE) -- BioNTech SE (Nasdaq: BNTX, “BioNTech”) and CureVac N.V. (Nasdaq: CVAC, “CureVac”) today announced that they have entered into a definitive Purchase Agreement pursuant to which BioNTech intends to acquire all of the shares of CureVac, a clinical-stage biotech company developing a novel class of transformative medicines in oncology and infectious diseases based on messenger ribonucleic acid (“mRNA”). The all-stock transaction will bring together two highly complementary companies based in Germany and will build on BioNTech’s proven track record and established position in the global mRNA industry.