uniQure Soars 36% After FDA Biologics Chief Vinay Prasad Announces April Exit
Prasad’s planned departure is prompting investors to bet on a more flexible review path for uniQure’s Huntington’s gene therapy.
Overview
- RBC Capital upgraded QURE to Outperform, lifted its price target to $35 from $11, and now pegs AMT-130’s approval odds at 50%.
- Gene therapy peers rallied on the news, with REGENXBIO up 13% and Biohaven gaining 23%.
- Prasad directly oversaw AMT-130’s review, and analysts noted reports that he overruled internal FDA reviewers on multiple programs.
- The FDA previously told uniQure it would not accept natural-history comparisons for approval and requested a full phase 3 trial.
- uniQure plans a Type B meeting with the FDA in the second quarter of 2026 to discuss the regulatory path, with Prasad set to leave in April.