uniQure (QURE) is rated a Speculative Buy with a $47 price target, implying 115% upside. QURE's Huntington's gene therapy BLA is under FDA accelerated review, with a decision expected around November 1. Three-year data met both FDA endpoints, showing 75% slowing of composite and 60% slowing of Total Functional Capacity.
QURE's Huntingtons gene therapy shows sustained functional benefits at 36 months, but mixed 48-month data add uncertainty.
uniQure N.V. (QURE) Discusses Additional Data from Phase I/II AMT-130 Study in Huntington's Disease Highlighting Disease Progression Slowing Transcript
Uniqure stock plummeted Tuesday on a disappointing four-year update for its experimental gene therapy in patients with 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.
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 (QURE) reported earnings 30 days ago. What's next for the stock?
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.
QURE is sharpening its gene therapy focus through faster regulatory pathways, a streamlined business model and CNS pipeline expansion, with AMT-130 at the center.
QURE's AMT-130 is driving investor focus as FDA feedback, a targeted third-quarter 2026 filing and cash into 2029 shape its regulatory outlook.