uniQure Provides Regulatory Update on AMT-130 for Huntington’s Disease

uniQure poleaxed as FDA blocks Huntington's therapy

uniQure has revealed that the FDA has said it is not prepared to review its Huntington's gene therapy in what seems to be a change in policy

UniQure Shares Dive After ‘Surprising’ Pivot by FDA on Drug Data

UniQure NV plunged Monday after the drug developer said US regulators deemed the clinical data for its experimental gene-therapy for Huntington’s disease as insufficient.

UniQure's FDA submission for its Huntington's disease therapy thrown into question

The company said the agency had changed its position on what level of data were sufficient for it to apply for approval for its gene therapy.

UniQure dives after FDA’s ‘very surprising’ reversal on Huntington’s gene therapy

The FDA’s abrupt shift on UniQure’s treatment reflects an agency that, under current leadership, is as unpredictable as its been in years, some analysts said.

uniQure Provides Regulatory Update on AMT-130 for Huntington’s Disease

LEXINGTON, Mass. and AMSTERDAM, Nov. 03, 2025 (GLOBE NEWSWIRE) -- uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative...

UniQure’s Roller-Coaster: Gene Therapy Breakthrough, FDA Setback, and What’s Next for QURE Stock

Stock Performance: Skyrockets and Crashes UniQure’s stock has been on a wild ride in 2025. After starting the year in the mid-teens, QURE shares skyrocketed through mid-2025 on hopes for its Huntington’s gene therapy. The rally hit a fever pitch in late September when Phase 1/2 trial data showed a remarkable 75% reduction in disease progression with AMT-130 – news that caused the stock to surge almost 200% that month reuters.com. By late October…