uniQure gains priority review for Huntington's gene therapy

UniQure's Huntington's disease gene therapy application is under FDA review with a decision expected by May 1. Teva Pharmaceuticals halted a mid-stage study of emrusolmin for multiple system atrophy due to futility. Bright Minds Biosciences' antiseizure drug trial was partially halted by the FDA. Specific Biologics raised $35M in Series A funding for ALS therapy trials. CinRx Pharma and Graviton BioScience formed a joint venture to develop cardiovascular drugs.

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's (QURE) Huntington's gene therapy received a priority review from the FDA, with a decision expected by May 1. Despite this, the company's stock fell at the open.