Class Action Looms Over uniQure: Lawsuit Alleges Misleading Statements in Huntington’s Drug Program—Key April 2026 Deadline

Securities Class Action Targets uniQure’s Disclosures on Huntington’s Drug AMT-130

uniQure N.V. (NASDAQ:QURE), a biotech company focused on gene therapies for rare diseases, is under scrutiny after a securities class action lawsuit was filed by Kessler Topaz Meltzer & Check, LLP. The suit alleges that between September 24, 2025, and October 31, 2025, uniQure made materially false or misleading statements about its pivotal clinical trial for AMT-130, a gene therapy for Huntington’s disease, and its progress towards seeking FDA approval.

Allegations Focus on Clinical Trial Design and FDA Communication

According to the complaint, uniQure is accused of overstating the rigor and acceptance of its clinical trial design—specifically, the reliance on external historical data for its pivotal study and the prospects for a timely FDA Biologics License Application (BLA) submission. The allegations state that:

• The FDA had not fully approved the comparison methodology between the AMT-130 trial and the external data set.
• uniQure downplayed the likelihood of further studies being needed, implying an accelerated pathway was likely.
• Forward-looking statements about the company’s drug development timeline and regulatory outlook lacked a reasonable basis.

Investor Disclosure Spurs Massive Stock Drop

The market’s reaction was swift when, on November 3, 2025, uniQure acknowledged that "the FDA currently no longer agrees that the data from the Phase I/II studies of AMT-130... may be adequate to provide the primary evidence" for a BLA submission. This admission cast doubt on the path to accelerated approval and left the timing of a potential application unclear. As a result, shares plunged more than 49%, falling by $33.40 per share in a single session, as investors digested the new uncertainty and regulatory hurdles.

Important Deadline for Investors: April 13, 2026

Investors who purchased or acquired shares in QURE during the class period have until April 13, 2026, to request lead plaintiff status. Becoming the lead plaintiff could provide a greater degree of involvement in the litigation but is not required to participate in any recovery. There is no cost or obligation for investors considering their legal options. For more information, affected investors can contact Kessler Topaz Meltzer & Check, LLP, through their website or by phone.

What’s Next For QURE Investors?

With the backdrop of an ongoing class action and regulatory uncertainty around AMT-130’s approval timeline, QURE’s share price has come under significant pressure. While legal processes can take time to play out, investors may want to monitor court developments and company disclosures closely, as outcomes here could materially impact future valuations and sentiment.

Whether this legal battle results in a recovery or prompts a change in regulatory strategy remains to be seen. What is clear: QURE is at a critical juncture, and its next steps—both in the courts and with the FDA—will be closely watched.

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