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On November 10, 2026, BioNTech SE agreed to acquire a US FDA Priority Review Voucher from Scholar Rock, Inc. for $205 million, intending to use it for a future late-stage oncology filing; closing requires customary conditions, including HSR clearance.
BioNTech SE reported revenue of 1,289.2 million euros for the three months ended September 30, 2026 and net profit of 184.5 million euros, while nine-month revenue was 1,512.9 million euros and net loss was 1,168.2 million euros.
BioNTech SE reported third-quarter revenue of €1,289.2 million and net profit of €184.5 million, raised full-year revenue guidance to €1,700 – €1,900 million, and reported €16.2 billion in cash, cash equivalents and security investments.
BioNTech SE and Bristol Myers Squibb Company reported first Phase 2 ROSETTA Lung-107 data: pumitamig plus docetaxel achieved a 36.7% confirmed objective response rate and 6.9-month median progression-free survival.
On October 26, 2026, BioNTech and DualityBio said DYNASTY-Breast02 achieved a statistically significant but modest progression-free survival improvement over chemotherapy; overall survival data were immature, and available data suggest limited patient benefit.
BioNTech SE and Gilead Sciences Inc. entered a clinical trial collaboration and supply agreement to evaluate pumitamig with sacituzumab govitecan in ROSETTA Breast-01 for first-line locally advanced or metastatic PD-L1 low or negative triple-negative breast cancer.
BioNTech will present new clinical data from its late-stage oncology pipeline via 16 abstracts spanning lung and breast cancer at the European Society for Medical Oncology 2026 Congress in Madrid, Spain, from October 23–27, 2026.
BioNTech SE reported that BNT113 plus pembrolizumab did not significantly improve progression-free survival versus pembrolizumab alone in the AHEAD-MERIT Phase 2/3 trial on October 13, 2026; the trial continues to assess overall survival, which could establish a positive outcome.
