uniQure Provides Regulatory Update on AMT-130 for Huntington’s Disease
uniQure N.V. - Ordinary Shares (QURE)
Last uniqure n.v. - ordinary shares earnings: 4/29 07:00 am
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Source: GlobeNewswire
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, today announced that the company received final meeting minutes from the U.S. Food and Drug Administration (FDA) regarding a pre-Biologics License Application (BLA) meeting held on October 29, 2025 to discuss the application for AMT-130, an investigational gene therapy for Huntington’s disease (HD). In the final meeting minutes, and consistent with uniQure’s November 3, 2025 press release, the FDA conveyed that data submitted from the Phase I/II studies of AMT-130 are currently unlikely to provide the primary evidence to support a BLA submission. uniQure is carefully evaluating the feedback and plans to urgently request a follow-up meeting with the FDA to take place in the first quarter of 2026. “We are committed to collaborating with the FDA to advance AMT-130 to patients and thei
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- QURE Investigation Alert: Kessler Topaz Meltzer & Check, LLP Encourages uniQure N.V. (NASDAQ: QURE) Investors with Significant Losses to Contact the FirmPR Newswire
- uniQure (NASDAQ:QURE) had its "buy" rating reaffirmed by analysts at Chardan Capital. They now have a $53.00 price target on the stock.MarketBeat
- Rare Stock Picks In November 2025 - From 14 Discerning Analysts [Seeking Alpha]Seeking Alpha
- QURE Investigation: Kessler Topaz Meltzer & Check, LLP Encourages uniQure N.V. (NASDAQ: QURE) Investors with Significant Losses to Contact the FirmGlobeNewswire
- uniQure (NASDAQ:QURE) was upgraded by analysts at <a style="font-weight:bold" href="https://www.wallstreetzen.com/newsletters/zen-ratings?ticker=QURE&utm_campaign=getratings&utm_medium=online&utm_source=MarketBeat">Wall Street Zen</a> frMarketBeat
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Earnings
- 11/10/25 - Miss
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Sec Filings
- 12/4/25 - Form 8-K
- 11/14/25 - Form SCHEDULE
- 11/14/25 - Form SCHEDULE
- QURE's page on the SEC website