United States — Food and Drug Administration & BioNTech

BioNTech: BioNTech is collaborating with Boehringer Ingelheim to evaluate a novel immuno-oncology combination in ES-SCLC. BioNTech will supply pumitamig and retains full rights to its asset.

BioNTech: BioNTech, in collaboration with Pfizer, halted a large U.S. trial for their updated COVID-19 vaccine due to low enrollment, potentially impacting future approvals and market share for the 50-64 age group.

BioNTech: BioNTech announced positive Phase 2 clinical trial results for trastuzumab pamirtecan, a HER2-targeted antibody-drug conjugate, in patients with endometrial cancer. This positive development could lead to a biologics license application in 2026 and further clinical trials, potentially increasing its market value and product pipeline.