BioNTech has agreed to acquire an FDA priority review voucher from Scholar Rock for $205 million in cash to support a future regulatory filing for a cancer treatment.
The Germany-based drugmaker plans to use the voucher for a candidate in its late-stage oncology pipeline, according to a Nov. 10 news release. The company did not specify which treatment would receive the expedited review.
Priority review vouchers allow drugmakers to shorten the FDA’s target review timeline for a single application, potentially accelerating a regulatory decision.
The transaction remains subject to customary closing conditions, including antitrust clearance under the Hart-Scott-Rodino Act.
BioNTech’s late-stage oncology pipeline includes immunomodulators, antibody-drug conjugates and mRNA-based cancer immunotherapies.
At the Becker's Perioperative Summit, taking place September 14–15 in Chicago, perioperative leaders and healthcare executives will focus on improving operating room efficiency, enhancing patient safety, optimizing staffing and driving innovation across surgical services. Apply for complimentary registration now.
