uniQure N.V. Stock News

~ FDA granted priority review of BLA for  ifezuntirgene inilparvovec (AMT-130) in Huntington's disease; PDUFA target action date of May 1, 2027 ~

The FDA said Monday it will make an approval decision on Uniqure's Huntington's gene therapy by May 1. But Uniqure stock fell.

~ FDA sets PDUFA target action date of May 1, 2027 ~ ~ If approved, ifezuntirgene inilparvovec will be the world's first disease-modifying treatment for Huntington's disease ~ LEXINGTON, Mass. and AMSTERDAM, Nov. 02, 2026 (GLOBE NEWSWIRE) -- uniQure N.V.

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UniQure says it still sees a path to regulatory approval for the drug candidate, AMT-130, even as the experimental gene therapy for Huntington's disease falls hort in a recent study.

Uniqure stock plummeted Tuesday on a disappointing four-year update for its experimental gene therapy in patients with Huntington's disease.

UniQure , said ​on Tuesday ‌its Huntington's treatment showed ​44% ​slowing of disease ⁠progression, but did ​not reach ​statistical significance in an ongoing ​early-to-mid-stage ​trial.