uniQure stock jumps after FDA backs 3-year AMT-130 data

Shares of uniQure nearly doubled on Wednesday after the company said the FDA agreed that three-year data from its Phase I/II study of AMT-130 can serve as the primary basis for a Biologics License Application seeking accelerated approval. uniQure plans to submit the BLA in the third quarter. The company issued the update on June 17.

The FDA discussed the data at a Type B meeting and indicated it would work expeditiously with uniQure to align on a design for a confirmatory study before the formal submission. Regulators said they would not necessarily require a full sham-surgery-controlled Phase 3 trial as a precondition for considering accelerated approval.

The stock moved sharply on the news. Shares climbed past key moving averages and pushed the relative strength index into the mid-80s. The price reached about $47 at the session high, roughly five times its level in the first week of March. Earlier in 2026 the share price had fallen toward $9 after the FDA rejected the use of an external control group as the primary efficacy comparator.

ClearPoint Neuro, whose surgical navigation system is used to deliver AMT-130, saw buying interest during the session.

AMT-130 is an experimental gene therapy for Huntington’s disease that has been evaluated in an early-stage clinical program with follow-up data extending to three years. Amsterdam-headquartered uniQure will move toward a formal U.S. regulatory filing based on those extended results and will continue interactions with the FDA as the companies align on confirmatory evidence.

Market participants are focused on the timing of the BLA submission in Q3 and on reaching agreement with the FDA on the design of the confirmatory trial.