Levi & Korsinsky LLP
03/24/2026 | Press release | Distributed by Public on 03/24/2026 08:03
uniQure or uniQuestion? Shareholders Challenge Statements on BLA Timeline
uniQure told investors it was on the brink of something historic.
A gene therapy that could actually slow Huntington's disease. FDA aligned. Data locked in. Approval on track for early 2026.
Then everything unraveled.
On September 24, 2025, uniQure announced its AMT-130 trial hit its main goal. They claimed a 75% slowing of disease progression. The stock exploded nearly 250% in a single day. By late October, shares were trading above $70. The company even raised about $345 million dollars to prepare for launch.
But on November 3, 2025, the FDA dropped a bombshell. It no longer agreed that the trial data was adequate primary evidence to support approval. The timeline? Suddenly unclear.
The stock collapsed about 49% in one day.
Now, investors are joining the lawsuit.
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