uniQure ($QURE) Alleged Misstatements About FDA Alignment and AMT-130 BLA Timeline Case

Investors can submit applications for the lead plaintiff role.

S.D. New York

Court

1:26-cv-01124

Case number

09/24/2025

Class period Start

10/31/2025

Class period End

04/13/2026

Lead Plaintiff motion deadline

$QURE investors filed a claim against uniQure for allegedly misleading investors about FDA alignment on its AMT-130 Pivotal Study.
After uniQure disclosed that the FDA backtracked on relying on the ENROLL-HD comparison for a BLA, and the filing timeline became unclear. $QURE fell 49.34% from $67.69 on October 31, 2025 to $34.29 on November 3, 2025.
$QURE investors can join this case to be notified about potential recovery.
Case Details:

Between Sept. 24, 2025 and Oct. 31, 2025, uniQure told investors AMT-130’s Pivotal Study delivered strong topline results and supported an accelerated approval path. The company said the FDA agreed the primary analysis could compare high-dose patients to a propensity score–adjusted ENROLL-HD external control, and reiterated a Q1 2026 BLA plan.
Investors allege that, in reality, the Pivotal Study design—especially the ENROLL-HD comparison—was not fully approved by the FDA, and uniQure downplayed the risk it would need additional studies that could delay the BLA.

On Nov. 3, 2025, uniQure disclosed the FDA no longer supported relying on the Phase I/II data versus ENROLL-HD as primary BLA evidence, leaving the BLA timeline uncertain. Shares fell over 49% to $34.29.

On Dec. 4, 2025, uniQure said FDA meeting minutes indicated the Phase I/II data were “currently unlikely” to serve as primary evidence for a BLA.

Based on these events, $QURE investors filed a claim against uniQure, alleging the company:
It misrepresented and/or failed to disclose that the design of uniQure’s Pivotal Study—including comparison to the ENROLL-HD external historical data set—was not fully approved by the FDA
It downplayed the likelihood that uniQure would need to delay its BLA timeline to perform additional studies to supplement its BLA submission
It misled investors about uniQure’s business, operations, and prospects, causing losses when the truth emerged
Investors argue uniQure misled the market about the regulatory status of its study design and the feasibility/timing of its AMT-130 approval pathway, causing losses when the FDA-related risks were disclosed.

Case Type

US Securities Class Action

Case Status

Lead Plaintiff Submission

Alleged Offence

Misleading Statements,

Financial Misrepresentation,

Failure to Disclose,

Omissions

Suspected Party

Management

Security Type

Stocks

Trade Direction

Long

Shock Event Date

11/03/2025

Filing date

02/10/2026

Lead Plaintiff Deadline

04/13/2026

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