Apellis Pharmaceuticals Inc. (APLS) said that the U.S. Food and Drug Administration has accepted the company's unsolicited major amendment to the New Drug Application or NDA for intravitreal pegcetacoplan for the treatment of geographic atrophy secondary to age-related macular degeneration or 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.
In Friday pre-market, APLS was trading at $50.00 up $6.76 or 15.63%.
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 in both studies.
Apellis said it 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.
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