uniQure N.V. is the subject of a class action securities lawsuit stemming from allegations that the biopharmaceutical company failed to disclose material information regarding its investigational gene therapy candidate AMT-130. The company had previously indicated a high probability of receiving FDA accelerated approval designation, positioning the drug candidate as a near-term commercial prospect.
On November 3, 2025, uniQure revealed that the FDA no longer considers the Phase I/II trial data sufficient to support a Biologics License Application (BLA) submission, a significant reversal from prior communications to the market. The disclosure triggered a substantial market reaction, with uniQure's stock price declining approximately 49 percent, closing at $34.29 compared to its previous level of $67.69.
Investors seeking to assume a lead plaintiff role in the litigation must submit applications by April 13, 2026. The firm has designated this deadline for parties with documented losses exceeding $100,000 to establish standing in the case. The lawsuit centers on whether uniQure's prior statements regarding FDA approval prospects constituted material misrepresentations or omissions to shareholders.