<div id="readability-page-1">07:40 AM EST, 12/04/2025 (MT Newswires) -- uniQure (QURE) said Thursday that it will &#34;urgently&#34; seek a follow-up&#34; meeting with the US Food and Drug Administration after the regulator said phase 1/2 studies of AMT-130 data are now unlikely to support a Biologics License Application submission.AMT-130 is an investigational gene therapy intended to treat patients with Huntington's disease, the company said.uniQure said it is evaluating the feedback and is looking to meet with the FDA in Q1.Shares of uniQure were down 19% in recent Thursday premarket activity. MT Newswires does not provide investment advice. Unauthorized reproduction is strictly prohibited.</div>

QURE

uniQure plans to urgently meet with the US FDA after being informed that phase 1/2 studies of AMT-130 data are unlikely to support a Biologics License Application. AMT-130 is a gene therapy for Huntington's disease. The company aims to meet with the FDA in Q1. uniQure's shares fell 19% in premarket trading.

uniQure Seeks US FDA Follow-Up Meeting After Being Told Data Do Not Support BLA Submission