Vinay Prasad to Leave FDA — What It Means for Biotech and Rare Disease Approvals

By FieldPulse Staff · March 17, 2026

Tags: leadership, strategy

Vinay Prasad exits FDA CBER effective end of April. His departure sparked a biotech rally — UniQure surged 36%. Gene therapy and rare disease developers expect a more favorable review environment.

Vinay Prasad, the controversial director of the FDA's Center for Biologics Evaluation and Research (CBER), announced his departure from the agency effective end of April 2026.

It is his second exit from the role following a brief departure in mid-2025.

FDA Commissioner Marty Makary said Prasad "got a tremendous amount accomplished" and will return to UCSF as a professor.

During his tenure, Prasad rejected Moderna's mRNA flu vaccine application (later reversed), imposed a higher bar on accelerated approvals for rare disease drugs, and presided over multiple surprise rejections that rattled the biotech sector.

His most contentious stance was his skepticism toward cell and gene therapy accelerated approvals, which he argued lacked confirmatory evidence of clinical benefit.

The market reacted immediately: UniQure surged 36% on the news, and gene therapy biotechs broadly rallied on expectations that a more favorable regulatory environment will follow.

Analysts at RBC Capital upgraded UniQure to Outperform with a price target of $35, citing roughly a 50% chance of approval for its Huntington's disease therapy AMT-130 under new leadership.

No replacement has been named by FDA Commissioner Makary.

Source: https://www.biopharmadive.com/news/vinay-prasad-fda-depart-cber-vaccines-makary/814121/