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FDA Accepts UniQure's BLA For Huntington's Gene Therapy; PDUFA Date In May '27

Source: Nasdaq

Healthcare & BiotechRegulation & Legislation

The FDA accepted uniQure’s biologics license application for ifezuntirgene inilparvovec, a gene therapy being developed to treat Huntington’s disease. Acceptance is a regulatory milestone, not an approval; the article provides no review timeline or market reaction.

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