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uniQure N.V.
Video analysis: QURE
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News: QURE
QURE Submits Application for Gene Therapy for Huntington's Disease
QURE seeks accelerated FDA approval for AMT-130, with Priority Review and a U.K. filing adding momentum to its regulatory push.
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uniQure Filed for Huntington's Approval. Acceptance Is the Catalyst, Analyst Says
On Wednesday, uniQure N.V. (NASDAQ:QURE) submitted its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for the accelerated approval of ifezuntirgene inilparvovec (AMT-130), an investigational gene therapy for Huntington's disease.
uniQure seeks US approval for Huntington's gene therapy after FDA reversal
Dutch gene therapy developer uniQure said on Wednesday it had applied for U.S. approval of its experimental treatment for Huntington's disease after the FDA reversed its earlier position on the drug, sending the company's shares up 5% in premarket trading.
uniQure Announces Submission of Biologics License Application for Ifezuntirgene Inilparvovec (AMT-130) in Huntington's Disease
~ Company also announces the submission of a Marketing Authorisation Application for ifezuntirgene inilparvovec in the U.K. ~ ~ Both submissions are supported by the three-year data analysis from the Phase I/II study, in which ifezuntirgene inilparvovec demonstrated a slowing of disease progression ~ LEXINGTON, Mass. and AMSTERDAM, Sept.
Why Is uniQure (QURE) Up 17.5% Since Last Earnings Report?
uniQure (QURE) reported earnings 30 days ago. What's next for the stock?
Are Biotech Stocks The 'Comeback Kid' Of 2026? I Say Yes
Biotech, especially small-cap names, is experiencing renewed optimism as macro and policy headwinds subside, driving sector-wide rallies. Stabilization at the FDA and a resurgence in M&A and IPO activity are restoring capital flows and investor confidence in biotech equities.
QURE Q2 Earnings Miss Estimates on Higher Costs, Revenues Rise Y/Y
uniQure posts a wider Q2 2026 loss as revenues missed estimates, but regulatory progress for AMT-130 and a cash runway into 2030 keep its pipeline in focus.
