Apellis Pharma Shares Jump As FDA Accepts Its Lead Product Application For Eye Disease
The FDA has accepted for review Apellis Pharmaceuticals Inc's (NASDAQ: 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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