Uni Qure shares spiked 65% after the FDA said data from its existing Huntington’s study could support an expedited approval filing.

The decision reverses a prior demand for a sham brain surgery and clears the way for a Q3 application. Investors had flipped on last fall after the company reported a 75% slower disease progression in high‑dose patients.

The shift follows the exit of former commissioner Marty Makary and Vinay Prasad, whose stricter stance on gene‑therapy trials had stalled progress. Similar leniency appeared when regulators reconsidered Replimune’s skin‑cancer drug.

Uni Qure’s therapy involves a 10‑hour brain infusion. Critics argue that a sham operation would expose patients to unnecessary risks and delay treatment, prompting the company to reject the required placebo arm.