Shares of Apellis Pharmaceuticals (NASDAQ: APLS) popped in pre-market trading on Friday after the biopharmaceutical company announced that the U.S. Food and Drug Administration (FDA) had accepted the company’s unsolicited major amendment to the New Drug Application (NDA) for intravitreal pegcetacoplan. Intravitreal pegcetacoplan is used in the treatment of geographic atrophy (GA) in late-stage age-related macular degeneration (AMD).
“The updated Prescription Drug User Fee Act (PDUFA) goal date is February 26, 2023.”
Cedric Francois, M.D., Ph.D., CEO and Co-Founder, Apellis commented, “With the inclusion of the 24-month data, we have the potential to have the best product profile at launch for pegcetacoplan, with minimal impact to launch timing. We appreciate the opportunity for the FDA to review these data and look forward to working with the agency to bring this first potential therapy to people living with GA as quickly as possible.”