FDA Signals uniQure Huntington Gene Therapy Data Could Back Accelerated Approval - uniQure (NASDAQ:QURE)

uniQure N.V.

(NASDAQ:QURE) stock is up during Wednesday's premarket session as the company announced plans for a Biologics License Application (BLA) submission for AMT-130, a gene therapy treatment for Huntington's disease.

FDA Opens Accelerated Approval Path This news comes following a Type B meeting with the FDA, where the agency indicated that the three-year analysis from the Phase I/II study could serve as the primary basis for accelerated approval.

The company intends to submit the BLA in the third quarter of 2026.

Read Also: What's Going On With Replimune Stock On Tuesday? uniQure FDA Update On AMT-130 BLA Path The FDA's acceptance of the three-year analysis as a basis for the BLA submission marks a significant milestone for uniQure.