uniQure Stock Soars 36% After FDA CBER Chief Resignation
uniQure shares jumped 36% after the head of the FDA’s CBER division, Vinay Prasad, announced his departure, prompting sector-wide analyst upgrades. RBC Capital raised uniQure’s rating to Outperform with a $35 price target and sees a 50% approval probability for its Huntington’s disease gene therapy.
1. Stock Reaction
uniQure shares surged 36% on Monday following news of Vinay Prasad’s forthcoming departure as head of the FDA’s CBER division, while peer gene therapy stocks also posted gains—Regenxbio rose 13% and Biohaven gained 23%.
2. Analyst Upgrades
RBC Capital upgraded uniQure to Outperform and lifted its price target from $11 to $35, reflecting a reassessed 50% approval probability for the company’s Huntington’s disease gene therapy. Stifel and Truist analysts also highlighted the potential regulatory shift toward a more balanced stance on rare disease programs.
3. Regulatory Impact
Prasad’s tenure introduced stricter review standards and shifting criteria for gene therapy candidates, causing development delays. His exit is expected to restore collaborative dialogues on clinical plans and reduce the FDA’s previous risk-off posture on rare and serious disease treatments.
4. Upcoming Milestones
uniQure has a Type B meeting scheduled with the FDA in the second quarter, which could clarify the regulatory pathway for its Huntington’s disease treatment and establish timelines for potential approval decisions.