uniQure (QURE) Stock Soars 36% as FDA’s Vinay Prasad Plans April Exit

Key Takeaways

• Shares of uniQure (QURE) climbed 36% on Monday following news that Vinay Prasad will step down from his role at the FDA’s Center for Biologics Evaluation and Research
• Prasad had been responsible for regulatory decisions regarding uniQure’s AMT-130, an experimental Huntington’s disease treatment
• Investment bank RBC Capital moved QURE from Sector Perform to Outperform, boosting their target from $11 to $35
• Other gene therapy stocks also rallied: REGENXBIO (RGNX) climbed 13% while Biohaven (BHVN) surged 23%
• The company plans a Type B meeting with FDA regulators during the second quarter of 2026

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The past several days have brought dramatic swings for uniQure shares. When an FDA representative publicly criticized the biotech firm on March 5 for allegedly conducting “a distorted or manipulated comparison” during its phase 1/2 study of AMT-130, a Huntington’s disease therapy, shares nonetheless rallied 18% by market close.

uniQure N.V., QURE

The following day, March 6, reports surfaced that Vinay Prasad—who leads the FDA’s Center for Biologics Evaluation and Research (CBER)—plans to depart the regulatory agency in April for an academic position. QURE shares rocketed 34% higher that session, extending gains to 36% by Monday’s close.

As CBER’s director, Prasad had direct oversight of the regulatory review process for AMT-130. The agency informed uniQure that approval wouldn’t be granted based on natural history comparisons—a stance the company described as a “key shift” from prior understandings reached before new FDA leadership took charge.

Regulators also demanded that the company conduct a complete phase 3 clinical trial, representing a significant financial and timeline burden for a therapy targeting a rare condition.

Prasad’s announced exit has dramatically altered the outlook among Wall Street analysts and market participants. RBC Capital’s Luca Issi moved his rating on QURE to Outperform from Sector Perform while tripling his price objective to $35 from $11. His updated analysis now assigns 50% probability to eventual AMT-130 approval.

Wall Street Weighs In

Analysts at Truist observed that Prasad’s leadership “marked a sharp departure from the more flexible regulatory approach for rare and serious diseases” that characterized the tenure of Peter Marks, his predecessor. Several pharmaceutical companies encountered changing regulatory expectations that contradicted earlier agreements reached during development discussions with the agency, they noted.

The gene therapy industry experienced broad-based gains. Shares of REGENXBIO (RGNX) advanced 13% on the development, while Biohaven (BHVN) posted a 23% gain.

The Road Ahead for uniQure

The biotech company has secured a Type B meeting with FDA officials planned for Q2 2026. This consultation will prove critical as the company seeks clarity on regulatory requirements for AMT-130’s approval pathway.

Prasad’s official departure date is set for April.

Interestingly, on March 5—the same day public criticism emerged from the FDA official regarding uniQure’s trial methodology—shares still managed to finish 18% higher, suggesting investors were already factoring in the potential impact of Prasad’s regulatory stance on the drug’s prospects.

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