uniQure Shares Surge Over 30% as FDA Biologics Chief Exits
uniQure shares surged 31% premarket and had jumped 34% Friday after FDA’s biologics division head, Dr. Vinay Prasad, announced his April departure. Prasad’s tenure included rejection of uniQure’s Huntington’s gene therapy application, and his exit removes a key regulatory obstacle for AMT-130.
1. Leadership Change at FDA Biologics Division
Dr. Vinay Prasad, head of the FDA’s Center for Biologics Evaluation and Research, will step down at the end of April. Prasad was first named to the role in May 2025, left in July, was rehired in August 2025, and has overseen evaluation of cancer drugs, gene therapies and vaccines.
2. Regulatory Disputes Over AMT-130
Under Prasad’s leadership, the FDA advised against using Phase 1/2 data alone for uniQure’s AMT-130 Huntington’s disease application and requested a prospective, randomized, double-blind sham surgery-controlled study. This stance created uncertainty around the therapy’s approval pathway and sparked debate over placebo-controlled trials in rare diseases.
3. Market Reaction
uniQure shares jumped 33.99% on Friday to close at $14.27 and then surged 31.39% to $18.75 in premarket trading Monday, extending gains after Prasad’s exit announcement. Reports indicate the stock rallied as much as 70% in post-market trading following the news.
4. Implications for uniQure's Approval Path
With Prasad’s departure, uniQure may face a more flexible regulatory environment for AMT-130, potentially avoiding large sham-controlled trials. The company could leverage FDA guidance that allows accelerated approval in rare diseases without placebo arms, reducing trial complexity for its gene therapy.