regulatory
confidence high
sentiment positive
materiality 0.80
FDA grants Priority Review for Apellis' pegcetacoplan to treat geographic atrophy; PDUFA Nov 26, 2022
Apellis Pharmaceuticals, Inc.
- FDA accepted and granted Priority Review for intravitreal pegcetacoplan NDA for geographic atrophy (GA).
- PDUFA target action date set for November 26, 2022; no advisory committee meeting planned.
- Apellis plans to submit marketing authorization application to European Medicines Agency in H2 2022.