FDA official resignation drives uniQure stock up 36%

LootboxPhobia · 2026-03-09T20:54:31+00:00

uniQure stock price rose 36% following the departure of the head of FDA's vaccine and gene therapy divisions, with analysts upgrading ratings for several biotech companies. Vinay Prasad's departure is seen as a positive for the industry, potentially improving the regulatory environment, especially for the approval prospects of Huntington's disease treatments.

LootboxPhobia

2026-03-09 20:54:31

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Investing.com - uniQure BV (NASDAQ:QURE) stock surged 36% on Monday after reports that the head of the FDA’s Vaccines and Gene Therapy Division is about to leave. This news prompted several analysts to upgrade their ratings on the biotech sector. REGENXBIO (NASDAQ:RGNX) rose 13%, and Biohaven (NYSE:BHVN) increased 23%.

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Vinay Prasad will leave the Center for Biologics Evaluation and Research next month to return to academia. During his tenure, gene therapy companies faced regulatory uncertainties.

RBC Capital analyst Luca Issi upgraded uniQure from sector perform to outperform, raising the target price from $11.00 to $35.00. The company recently faced setbacks after the FDA stated it would not approve its Huntington’s disease treatment based on comparisons with natural history. uniQure described this as a “significant shift” compared to previous communications before the new FDA leadership took office.

Issi wrote, “We believe Prasad’s departure could open a more balanced risk/reward discussion for Huntington’s disease.” The analyst now estimates a 50% chance of eventual approval for the drug.

Stifel analyst Paul Matteis described Prasad’s departure as a “major positive for the biotech industry, especially for companies in the rare disease field.” Matteis noted that several gene therapy and rare disease companies are under pressure in the “FDA risk mitigation” category, and reports suggest Prasad had overruled review teams and issued negative recommendations.

Truist analyst commented that Prasad’s tenure “marked a sharp departure from the more flexible regulatory approach taken by his predecessor, Peter Marks, for rare and serious diseases.” Under Prasad’s leadership, many companies faced regulatory standard shifts that had been previously agreed upon during development discussions.

uniQure has scheduled a Type B meeting in the second quarter.

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