FDA’s Prasad Departure Drives 16% Jump in Regenxbio Shares
FDA’s vaccines and gene therapies chief Vinay Prasad will leave the agency next month after overruling scientific review staff and shifting approval requirements. News of his departure sent Regenxbio shares up 16% in postmarket trading following last month’s rejection of its Hunter syndrome gene therapy.
1. Prasad to Depart FDA Center for Biologics Evaluation and Research
Vinay Prasad will step down next month and return to academia, capping a tenure that began in May 2025. His confrontational oversight, including overruling his own scientific staff and altering approval standards, drew criticism for hindering innovation despite a record number of approvals in December.
2. Market Reaction and Share Movements
News of Prasad’s exit spurred a 16% postmarket surge in Regenxbio shares, with investors optimistic about regulatory relief. UniQure NV also jumped 55%, reflecting broader biotech relief after Prasad’s stringent review policies.
3. Potential Impact on RGNX Pipeline
Stakeholders anticipate that a new FDA vaccines division head may implement more consistent guidance, potentially easing the approval pathway for Regenxbio’s rare-disease gene therapies, including its recently rebuffed Hunter syndrome treatment.