A securities class action lawsuit has been initiated against uniQure N.V., alleging the biopharmaceutical company made materially false and misleading statements regarding the regulatory pathway for its AMT-130 drug candidate. The complaint centers on statements allegedly misrepresenting the FDA's position on whether Phase I/II clinical study data would suffice for a Biologics License Application submission.
The legal action was prompted by an FDA disclosure on November 3, 2025, in which the agency reversed its previous stance on the adequacy of Phase I/II data for AMT-130's approval pathway. Following this announcement, uniQure's stock experienced a significant decline, dropping 49 percent from $67.69 to $34.29 per share during the period between September 24 and October 31, 2025.
Investors who sustained losses exceeding $100,000 during the specified timeframe have until April 13, 2026, to submit applications for lead plaintiff status in the litigation. The law firm Faruqi & Faruqi, LLP is administering the class action and urging eligible shareholders to take timely action before the deadline expires.