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uniQure QURE

uniQure announces FDA accepted BLA for ifezuntirgene inilparvovec

Item 7.01 Investor disclosure, Item 8.01 Other events

Form
8-K
Filed
Importance
Notable
  1. FDA accepted BLA for ifezuntirgene inilparvovec for Huntington's disease
  2. Priority Review with PDUFA target action date of May 1, 2027
  3. Confirmatory study design includes 200 patients with TFC as primary endpoint
  4. Ifezuntirgene inilparvovec has Breakthrough Therapy and RMAT designations

Written from the 8-K on EDGAR. AI can make mistakes. Check the filing.

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Data on this page was fetched . The filing on SEC.gov is the record.