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

MT Newswires Live12-04

uniQure (QURE) said Thursday that it will "urgently" seek a follow-up" 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.

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