UniQure Shares Surge 70% after FDA Division Chief Departure
The FDA’s vaccine and gene therapies head, Vinay Prasad, will leave next month after a contentious tenure marked by scientific review overrulings and strict testing demands, boosting biotech approval prospects. UniQure shares surged 70% in after-hours trading after a public feud with the division over its Huntington’s disease gene therapy requirements.
1. FDA Chief Prasad Departure
Vinay Prasad will step down as head of the FDA’s Center for Biologics Evaluation and Research next month, returning to academia after a tenure that saw frequent overruling of his scientific review staff and adoption of additional testing requirements for vaccines and rare disease drugs. The agency intends to name a successor before his departure, with industry analysts forecasting quicker regulatory decisions under new leadership.
2. UniQure Stock Reaction and Feud
UniQure stock jumped 70% in postmarket trading following news of Prasad’s exit, reflecting investor optimism that the change could remove obstacles stemming from a public dispute over the FDA’s requirements for its Huntington’s disease gene therapy. The company and its supporters have argued that rigid data demands delayed the therapy’s approval process.
3. Broader Gene Therapy Regulatory Outlook
Prasad’s departure may herald a shift toward more collaborative FDA-industry relations, potentially speeding reviews for novel therapies. Market participants will watch the nomination of his successor closely, as any policy adjustments could influence approval timelines across the gene therapy sector.