- The FDA has accepted for review Apellis Pharmaceuticals Inc's APLS unsolicited major amendment to the New Drug Application (NDA) for intravitreal pegcetacoplan for geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
- The updated Prescription Drug User Fee Act (PDUFA) goal date is February 26, 2023.
- The FDA also restated that they do not plan to hold an advisory committee meeting to discuss the application.
- "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," said Cedric Francois, CEO & co-founder.
- Apellis announced earlier this month the company's decision to submit 24-month efficacy data from the Phase 3 DERBY and OAKS studies as part of the NDA review.
- The 24-month data showed increasing and consistent effects with every-other-month and monthly pegcetacoplan treatment and a favorable safety profile.
- Apellis remains on track to submit an EU marketing authorization application, which will also include the 24-month results, to the European Medicines Agency by the end of 2022.
- Price Action: APLS shares are up 19.8% at $51.79 on the last check Friday.
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