uniQure disclosed the FDA will not accept Phase I/II data alone for AMT-130 approval, causing shares to drop 49%. The company held regulatory meetings and reported $622.5 million in cash while investors face an April 13 class action deadline.
A securities fraud class action lawsuit has been filed against uniQure N.V. alleging material misstatements about its Huntington's disease gene therapy AMT-130 and FDA approval pathway between September and October 2025.
Multiple law firms have filed securities fraud class actions against uniQure N.V. after the FDA reversed its position on the company's AMT-130 Huntington's disease drug candidate, causing shares to plummet 49% in a single day.
