BioNTech targets FDA approval for BNT323 cancer therapy as oncology pipeline expands

BioNTech AG plans to file a United States Food and Drug Administration (FDA) application for its antibody‑drug conjugate BNT323 (trastuzumab pamirtecan) in 2026. The drug, aimed at HER2‑expressing endometrial cancer, showed a confirmed overall response rate of 47.9 % in a mid‑stage study, rising above 70 % in the highest HER2‑expression subgroup. The company views BNT323 as a keystone of a broader oncology portfolio that now includes more than two dozen studies across multiple cancer types.

The firm’s shift from Covid‑19 vaccine production to cancer therapeutics has coincided with a decline in its share price, which fell to €76.65, down 7 % year‑to‑date and 19.5 % over twelve months. BioNTech reported €2.87 billion in revenue for 2025 but posted operating and net losses of €1.40 billion and €1.14 billion respectively. Analysts remain divided, with some upgrades to “Buy” and others maintaining a “Market Perform” rating.

Following a successful phase‑3 trial of BNT323 conducted in China with partner Duality Biologics, BioNTech intends to seek regulatory approval not only in the United States but also in the European Union and China. The company’s broader strategy combines mRNA‑based immunotherapies, next‑generation immunomodulators and targeted therapies to build a curative oncology platform.