FDA accepts pegcetacoplan for priority review as GA therapy
US biopharma firm Apellis Pharmaceuticals (Nasdaq: APLS) today announced that the US Food and Drug Administration (FDA) has accepted and granted Priority Review designation for the intravitreal pegcetacoplan New Drug Application (NDA).
The news was greeted with approval by investors, sending the firm’s shares soaring more than 26% to $56.44 in mid-morning trading.
Pegcetacoplan is an investigational, targeted C3 therapy for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The Prescription Drug User Fee Act (PDUFA) target action date is November 26, 2022. The FDA has stated that it is not currently planning to hold an advisory committee meeting to discuss the application.
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