uniQure Says FDA Grants Priority Review to Huntington’s Gene Therapy

uniQure said Monday the U.S. Food and Drug Administration (FDA) accepted its biologics license application for investigational Huntington’s disease gene therapy ifezuntirgene inilparvovec, also known as AMT-130, and granted Priority Review. The agency set May 1, 2027, as the target action date. The application seeks accelerated approval. uniQure said the FDA’s acceptance letter tentatively proposed an advisory committee discussion, but no meeting date or timeline has been set. The company submitted the application on Sept. 2, requesting Priority Review; the May 1 date is a target for FDA action, not an approval.

Source: TokenPost