Mergers & Acquisitions ·
BioNTech agrees to acquire FDA Priority Review Voucher from Scholar Rock for $205 million
BNTXBioNTech SE
BioNTech SE has entered into an agreement to purchase a US Food and Drug Administration (FDA) Priority Review Voucher (PRV) from Scholar Rock, Inc. for $205 million in cash. The PRV grants priority review status for a single regulatory application, potentially reducing the FDA review timeline and facilitating expedited approval. BioNTech intends to utilize this voucher to support a future filing for an asset within its late-stage oncology pipeline. The transaction remains subject to customary closing conditions, including clearance under the Hart-Scott-Rodino Antitrust Improvements Act. BioNTech is a global biopharmaceutical company pioneering novel investigative therapies for cancer and other serious diseases.