FDA's Rigid Approach Adds Uncertainty To uniQure's Accelerated Pathway For Huntington's Gene Therapy - uniQure (NASDAQ:QURE)

FDA's Rigid Approach Adds Uncertainty To uniQure's Accelerated Pathway For Huntington's Gene Therapy - uniQure (NASDAQ:QURE)

The U.S. Food and Drug Administration (FDA) on Monday provided feedback to uniQure N.V. (NASDAQ:QURE) regarding its investigational gene therapy for Huntington's disease. QURE is among today's weakest performers. Stay ahead of the curve here uniQure believes that the FDA currently disagrees that the data from the Phase 1/2 studies of AMT-130, in comparison to an external control, as per the prespecified protocols and statistical analysis plans …

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...