uniQure N.V. [QURE] Securities Class Action Lawsuit Update

• Case Name: Scocco v. uniQure N.V. et al.
• Case No.: 1:26-cv-01124
• Jurisdiction: U.S. District Court, Southern District of New York
• Filed on: February 10, 2026
• Class Period: September 24, 2025 – October 31, 2025

Introduction

uniQure N.V. once told investors it was standing on the edge of a breakthrough. By early November 2025, that edge collapsed.

A federal securities class action now alleges that uniQure and several senior executives misled investors about the regulatory viability of its flagship Huntington’s disease gene therapy, AMT-130, and the degree of alignment with the U.S. Food and Drug Administration regarding a planned accelerated approval pathway. According to the complaint, those alleged representations coincided with a sharp increase in uniQure’s share price and were followed by a reversal after the company disclosed that the FDA ‘currently no longer agrees’ the external-control comparison may be adequate as primary evidence for a Biologics License Application (“BLA”), contributing to a single-day decline of more than 49%.

The lawsuit seeks to represent investors who purchased uniQure ordinary shares between September 24, 2025 and October 31, 2025, a narrow but volatile window defined by soaring expectations and an abrupt regulatory reversal.

“Most QURE shareholders never file or join the class action, which means they miss out on potential recovery funds,” said Attorney Joseph Levi.

Backdrop and Business Context

uniQure is a Netherlands-based biotechnology company developing gene therapies for rare diseases, including Huntington’s disease, ALS caused by SOD1 mutations, refractory mesial temporal lobe epilepsy, and Fabry disease. The complaint describes AMT-130 as the company’s leading drug candidate and one of a small number of therapies being studied to slow the progression of Huntington’s disease.

According to the complaint, defendants represented that results from the Phase I/II study could be compared to an external historical dataset known as ENROLL-HD and that this analysis could potentially support a future BLA submission. That premise underpinned everything that followed.

Promises Made vs. Reality

According to the complaint, uniQure executives repeatedly assured investors that the FDA supported both the trial design and the statistical framework underlying AMT-130’s pivotal data readout.

In June and July 2025, CEO Matthew Kapusta told investors that the FDA had agreed the primary efficacy analysis would rely on changes in the composite Unified Huntington’s Disease Rating Scale (cUHDRS), comparing high-dose AMT-130 patients against propensity-matched ENROLL-HD controls. On a July 2025 earnings call, Kapusta rejected concerns that FDA leadership might later reverse course, stating the company had received “very clear and unambiguous feedback” from the agency.

Those assurances intensified on September 24, 2025, when uniQure announced topline Phase I/II results. The company claimed a 75% slowing of disease progression on the primary endpoint, strong secondary outcomes, and favorable biomarker trends. Executives described the data as “clinically meaningful,” “compelling,” and “game changing,” while reiterating that the FDA had accepted the external-control approach.

The complaint alleges that investors were led to believe there was a high likelihood of accelerated approval following a planned BLA submission in the first quarter of 2026.

The lawsuit alleges that this confidence masked a critical omission: the FDA had not, in fact, fully agreed that the external-control comparison would be sufficient to support a BLA.

Timeline of Alleged Misconduct and Disclosures

The alleged misconduct unfolded quickly.

On September 24, 2025, uniQure released its topline AMT-130 data. The stock exploded, closing at $47.50, up nearly 250% in a single day. By late October, shares traded above $70.

Within days, the company launched a public offering of more than 5.7 million shares and 500,000 pre-funded warrants, raising approximately $345 million. The prospectus stated that proceeds would fund commercialization readiness and a potential AMT-130 launch.

On November 3, 2025, the narrative collapsed. uniQure disclosed that the FDA “no longer agrees” that the Phase I/II data, when compared to ENROLL-HD controls, could serve as primary evidence for a BLA. The company admitted the approval timeline was now unclear.

The market response was brutal. Shares fell $33.40 in one day, a decline of more than 49%.

Investor Harm and Market Reaction

The lawsuit ties investor losses directly to the alleged corrective disclosure. According to the complaint, the stock’s rapid ascent reflected investor reliance on management’s statements about FDA alignment and regulatory readiness.

When those statements were contradicted, nearly half of the company’s market value evaporated overnight. Plaintiffs allege that investors who purchased during the Class Period paid artificially inflated prices driven by misleading assurances about approval probability, trial sufficiency, and regulatory consensus. The magnitude and speed of the decline, they argue, demonstrate classic loss causation under the federal securities laws.

Litigation and Procedural Posture

The action is pending in the U.S. District Court for the Southern District of New York, styled Scocco v. uniQure N.V., et al., Case No. 1:26-cv-01124.

The complaint asserts claims under Section 10(b) of the Securities Exchange Act and Rule 10b-5, as well as Section 20(a) against individual executives. Defendants include uniQure and senior officers Matthew Kapusta, Christian Klemt, Walid Abi-Saab, and Sarah Tabrizi.

Plaintiffs allege that defendants knowingly or recklessly misrepresented FDA agreement, downplayed regulatory risk, and promoted commercialization timelines lacking a reasonable basis. The complaint also alleges motive and opportunity tied to the September 2025 equity offering.

The case remains at the pleading stage.

Shareholder Sentiment

Market sentiment shifted sharply during the class period, as reflected in the stock’s rapid rise after the September 24, 2025 update and the reversal following the November 3, 2025 FDA feedback. In September 2025, the company reported three-year AMT-130 data showing a 75% slowing of disease progression on cUHDRS, and the stock rose sharply as investors reacted to the update.

That enthusiasm reversed in early November when uniQure disclosed that the FDA “currently no longer agrees” the Phase I/II data and external-control comparison may be adequate as primary evidence for a BLA. The disclosure made the timing of a BLA submission unclear, and the market reaction reflected a sharp reassessment of the company’s near-term regulatory outlook.

For investors, the abrupt shift from optimism to uncertainty highlights how strongly valuations in development-stage biotechnology companies can hinge on regulatory expectations.

Discussions on Stocktwits ($QURE) during the crash highlighted a collapse in management credibility, with users shifting focus from clinical efficacy to "regulatory moving goalposts." High-volume threads on r/BiotechPlayes analyzed the delta between the September "alignment" claims and the November "disagreement," with many retail traders expressing a sense of being "trapped" by the secondary offering.

Analyst Commentary

The complaint references analyst commentary emphasizing the importance of FDA acceptance of the external-control comparison and the cUHDRS endpoint. Before the November 2025 disclosure, market commentary and coverage largely centered on whether AMT-130’s Phase I/II results and external-control approach could support an accelerated-approval filing. After the September 2025 data release and the resulting stock surge, attention increasingly centered on the possibility of a future BLA submission. After uniQure disclosed that the FDA no longer agreed the external-control comparison may be adequate, coverage emphasized that the regulatory timeline had become uncertain and that further evidence could be needed to support approval.

The market’s reaction aligns with the complaint’s theory that investor expectations were closely tied to perceived FDA alignment and the assumed regulatory pathway.

SEC Filings & Risk Factors

The complaint places particular weight on statements made in SEC filings and offering documents during the Class Period. Plaintiffs allege that the September 2025 prospectus portrayed commercialization and approval readiness without adequately disclosing the unresolved nature of FDA agreement on trial design.

According to the lawsuit, risk disclosures failed to convey the likelihood that additional studies might be required or that the external-control methodology could be rejected, omissions that plaintiffs claim rendered affirmative statements misleading.

Conclusion: Implications for Investors

The lawsuit centers on a brief but volatile period in which investor expectations for uniQure’s AMT-130 therapy rose rapidly following encouraging clinical data and then reversed after the company disclosed new FDA feedback.

According to the complaint, investors were led to believe the therapy’s existing data could support an accelerated regulatory pathway. When the company later revealed that the FDA questioned whether the available evidence would be sufficient for a Biologics License Application, the market reassessed that outlook and the stock fell sharply.

The case will ultimately test whether uniQure’s disclosures accurately reflected its regulatory discussions, as plaintiffs allege, and whether investors were given a complete picture of the risks surrounding the therapy’s approval strategy.

This is not a verdict. It is an allegation. But it is also a reminder of how regulatory narratives, especially when presented as more settled than regulators ultimately support, can reshape markets and lead to litigation.

How to Join the uniQure (QURE) Class Action

• Confirm you purchased QURE shares during the relevant period
• Review eligibility details
• Click here to check eligibility

Disclaimer: This shareholder alert is for informational purposes only and does not constitute legal advice. Consult a qualified attorney for personalized guidance. No specific outcomes are guaranteed.