uniQure Shares Surge 26% On US FDA Shakeup Even As Momentum Tumbles: Will New Leadership Greenlight Huntington's Therapy?

uniQure N.V. (NASDAQ:QURE) shares skyrocketed on Monday following news that Dr. Vinay Prasad, head of the FDA's Center for Biologics Evaluation and Research (CBER), will resign in April.

The Momentum Paradox

The stock jumped 26.07%, closing with significant gains as investors bet that his departure would ease the regulatory path for the company's Huntington's disease gene therapy, AMT-130.

Despite the massive single-day rally, Benzinga Edge’s Stock Rankings tell a more complex story. The stock's momentum score cratered week-on-week, falling from a robust 93.8 to a mere 28.01.

This ranking, which measures price strength and volatility relative to the broader market, reflects the heavy toll of recent months. Even with Monday’s surge, QURE remains down 24.82% Year-to-Date, highlighting a long-term downward trend that has yet to be fully reversed.

While the short-term price trend has turned green, Benzinga Edge rankings for medium and long-term trends remain bearish.

Regulatory Roadblocks Under Prasad

The market's enthusiasm stems from Dr. Prasad's history of “idiosyncratic decisions,” specifically his rejection of uniQure’s request for an expedited review of AMT-130.

Prasad had insisted on a randomized, double-blind, sham surgery-controlled study—a high bar for a rare disease requiring invasive brain surgery. Analysts at William Blair suggest his exit acts as a “tailwind” for rare disease sponsors who have struggled with his rigid stance on external controls.

Investors are now watching to see if the FDA will embrace “regulatory flexibility” for rare diseases, as recently hinted at by Commissioner Marty Makary. The new CBER leadership could allow uniQure to use Phase 1/2 data for accelerated approval.

QURE Underperforms In 2026

Despite QURE’s 24.82% YTD decline, it has risen by 2.86% in the last six months, and 47.10% over the year.

On Monday, the stock closed 26.07% higher at $17.99 apiece, and it was up 6.17% in premarket on Tuesday.

Disclaimer: This content was partially produced with the help of AI tools and was reviewed and published by Benzinga editors.

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This article uniQure Shares Surge 26% On US FDA Shakeup Even As Momentum Tumbles: Will New Leadership Greenlight Huntington's Therapy? originally appeared on Benzinga.com