BioSpace

FDA Minutes Confirm Challenging Path Ahead for UniQure’s Huntington’s Gene Therapy

Investor optimism has waned as final minutes from uniQure’s pre-BLA meeting with the FDA convey that data from the company’s ...

Why uniQure Stock Is Trading Lower After FDA Meeting Update

The gene therapy company received final meeting minutes from the FDA regarding a pre-Biologics License Application for ...

uniQure (QURE): Reassessing Valuation After FDA Doubts on AMT-130’s Path to Approval

Qure (NasdaqGS:QURE) just hit a regulatory speed bump, with the FDA signaling that early AMT-130 data probably will not carry a Biologics License Application, and the stock quickly reflected that ...
FiercePharma

AMT's Marketing Authorisation Application for Glybera(R) Progressing on Schedule

AMT expressly disclaims any intent or obligation to update these forward-looking statements except as required by law. For a more detailed description of the risk factors and uncertainties affecting ...

UniQure Shares Drop After More Negative News From FDA on Huntington's Disease Drug

UniQure shares fell Thursday after the gene therapy company said its Huntington's disease drug hit more regulatory roadblocks. Shares of the Lexington, Mass., company fell 15% early Thursday, to ...
The Manila Times

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

LEXINGTON, Mass. and AMSTERDAM, Dec. 04, 2025 (GLOBE NEWSWIRE) -- uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, ...

William Blair Maintains Market Perform Rating on uniQure (QURE) Despite AMT-130 Approval Uncertainty

Qure N.V. (NASDAQ:QURE) ranks among the most oversold biotech stocks to invest in. William Blair reaffirmed its Market ...
Yahoo Finance

uniQure Announces FDA Clearance of Investigational New Drug Application for AMT-260 Gene Therapy for Refractory Mesial Temporal Lobe Epilepsy

LEXINGTON, Mass. and AMSTERDAM, Sept. 05, 2023 (GLOBE NEWSWIRE) -- uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs ...
Nasdaq

uniQure Announces FDA Clearance of Investigational New Drug Application for AMT-191 Gene Therapy for Fabry Disease

LEXINGTON, Mass. and AMSTERDAM, Nov. 29, 2023 (GLOBE NEWSWIRE) -- uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, ...