QURE

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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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.

~ 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.

uniQure (QURE) reported earnings 30 days ago. What's next for the stock?

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.

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.

uniQure NASDAQ: QURE said it has aligned with the U.S. Food and Drug Administration on a potential accelerated-approval pathway for AMT-130, its investigational gene therapy for Huntington's disease, and remains on track to submit a biologics license application in the third quarter of 2026.

uniQure (QURE) came out with a quarterly loss of $1.22 per share versus the Zacks Consensus Estimate of a loss of $0.81. This compares to a loss of $0.69 per share a year ago.

~ U.S. and U.K. regulatory submissions for AMT-130 for Huntington's disease on track as planned for the third quarter of 2026 ~ ~ Topline four-year data from the Phase I/II study of AMT-130 expected in September 2026 ~ ~ Reported data from the first cohort in the Phase I/IIa trial of AMT-260 for refractory mesial temporal lobe epilepsy showed early biological signals of therapeutic activity and a favorable safety profile ~ ~ Strengthened financial position with $259 million follow-on offering, extending cash runway into 2030 and funding the anticipated commercial launch of AMT-130 and continued pipeline investment ~ ~ uniQure to host earnings call at 8:30 a.m. ET ~ LEXINGTON, Mass.