BioNTech to acquire FDA priority review voucher from Scholar Rock for $205 million

BioNTech SE announced on November 10, 2026 that it entered into an agreement to acquire a US Food and Drug Administration Priority Review Voucher from Scholar Rock, Inc. for a total cash consideration of $205 million.¹

A priority review voucher allows its holder to request that the FDA shorten its standard review period for a given application, offering a potential path to faster approval. Such a voucher grants FDA priority review for a single application, which reduces the target FDA review timeline and could lead to expedited approval.¹ BioNTech said it plans to apply the voucher toward a filing from its late-stage oncology programs. BioNTech intends to use the PRV to support a future filing of an asset in its late-stage oncology pipeline.¹

The deal still needs to clear standard conditions. The transaction is subject to customary closing conditions, including clearance under the Hart-Scott Rodino Antitrust Improvements Act.¹

BioNTech describes itself as a biopharmaceutical company focused on cancer and other serious diseases, saying it is committed to transforming how cancer is treated and aims to develop medicines with pan-tumor or synergistic potential across early- to late-stage disease.¹ The company's oncology portfolio spans several drug classes, including immune-modulating agents, antibody-drug conjugates, and mRNA-based cancer treatments, and the company has said it works with outside partners such as Bristol Myers Squibb, Duality Biologics, Genentech, a member of the Roche Group, Genmab, MediLink, OncoC4, and Pfizer¹ on its research efforts.

The filing was submitted as a Form 6-K, with the press release attached as Exhibit 99.1, and signed by BioNTech Chief Financial Officer Ramon Zapata-Gomez and Chief Operating Officer Dr. Sierk Poetting.