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Thursday, November 3, 2022

Apellis to Submit 24-Month Phase 3 Data for Pegcetacoplan NDA for Geographic Atrophy

 

  • Inclusion of the 24-month data has the potential to strengthen the product profile at launch, with minimal impact to launch timing

  • Submission will be a Major Amendment to the New Drug Application (NDA), extending the review period by three months with an expected PDUFA target action date in February 2023

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