uniQure faces securities class action over AMT-130 FDA disclosures

Reuters03-19

uniQure faces securities class action over AMT-130 FDA disclosures

A securities class action lawsuit, Scocco v. uniQure, was filed in the U.S. District Court for the Southern District of New York covering purchasers of uniQure shares between Sept. 24, 2025, and Oct. 31, 2025. The suit alleges the company misrepresented its interactions with the FDA and used a pivotal study design that the agency had not approved. Allegations include that the FDA had not approved use of the ENROLL-HD external historical dataset as a primary control and that the need for a sham-controlled surgery arm was downplayed. The document states that the company’s shares fell 49% after a Nov. 3, 2025 disclosure that made the timing of a Biologics License Application unclear.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. uniQure NV published the original content used to generate this news brief via PR Newswire (Ref. ID: 202603181219PR_NEWS_USPR_____SF13330) on March 18, 2026, and is solely responsible for the information contained therein.

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