Uniqure's Reversal Continues; Huntington's Drug Lands At FDA

UniQure (QURE) announced the FDA accepted its BLA for Ifezuntirgene inilparvovec, a gene therapy for Huntington's disease. The FDA granted Priority Review, with a PDUFA date set for May 2027. The therapy received Breakthrough, RMAT, and Fast Track designations. QURE shares closed at $22.97, down 7.49%.

uniQure's gene therapy AMT-130 for Huntington's disease is under FDA priority review, with a decision expected by May 1, 2024. The FDA previously rejected the application but granted a priority review. Shares fell 7.5% post-announcement. uniQure aims for AMT-130 to be the first disease-modifying treatment, with a confirmatory trial set to begin screening by year-end. The therapy has shown improvements in disability progression measures.

uniQure's (QURE) gene therapy ifezuntirgene inilparvovec for Huntington's disease has received FDA Priority Review, with an action date of May 1, 2027. The FDA is tentatively planning an advisory committee meeting, according to the company.

UniQure received a review date and advisory committee meeting from the FDA. Inovia's stock surged following an approval. The article also mentions AbbVie, Gilead, and Tiziana Life Sciences.

uniQure (QURE) stock fell 5.7% after the FDA accepted its gene therapy application for Huntington's disease, setting a 2027 review date. Despite initial gains, shares dropped due to concerns over efficacy data and FDA advisory committee plans. Analysts are divided on the stock's outlook. The broader market is up, indicating the decline is company-specific.

UniQure's gene therapy for Huntington's disease, ifezuntirgene inilparvovec, has been accepted for FDA priority review with a May 1 decision date. The therapy showed a 75% slowing of disease in a Phase 1/2 trial. Analysts from Stifel and William Blair view the BLA acceptance as a positive sign. UniQure expects an advisory committee meeting and is planning a confirmatory trial.