Business

Add as a preferred source on Google

Scholar Rock Agrees to Transfer FDA Voucher to BioNTech for $205 Million

BioNTech expects to use the voucher for an application involving a cancer candidate already in its late-stage pipeline.

Updated 1 min read
BioNTech’s headquarters and research buildings stand beside a quiet street in Mainz, Germany. / EconoTimes.ai
BioNTech’s headquarters and research buildings stand beside a quiet street in Mainz, Germany. / EconoTimes.ai

A $205 million agreement announced Tuesday, Nov. 10, would move Scholar Rock’s priority review voucher to BioNTech for a future cancer application seeking faster review by the U.S. Food and Drug Administration (FDA).

BioNTech said the application would involve a candidate from its more advanced oncology program. The voucher allows a single chosen filing to receive priority handling, with a shorter target period for FDA review.

An earlier Ultragenyx voucher sale was valued at $203 million, $2 million below the Scholar Rock agreement. The agreement pairs Scholar Rock as seller with BioNTech as the intended user.

Among the remaining requirements is clearance under the Hart-Scott-Rodino Antitrust Improvements Act. BioNTech is due to pay when the deal closes.

Related articles

View all