Apellis Pharmaceuticals Inc APLS shares are trading higher Tuesday after the company announced the U.S. Food and Drug Administration accepted and granted priority review designation for the new drug application for Pegcetacoplan.
Pegcetacoplan is an investigational, targeted C3 therapy for the treatment of geographic atrophy secondary to age-related macular degeneration.
The FDA has stated that it is not currently planning to hold an advisory committee meeting to discuss Apellis' application. The Prescription Drug User Fee Act target action date is Nov. 26.
The NDA submission is based on results from the Phase 3 DERBY and OAKS studies, as well as the Phase 2 FILLY study. In the studies, treatment with both monthly and every-other-month pegcetacoplan resulted in a clinically meaningful reduction of GA lesion growth across a broad, heterogeneous population of more than 1,500 patients. Pegcetacoplan demonstrated a favorable safety profile in all three studies.
APLS Price Action: Apellis has traded between $69.60 and $27.50 over a 52-week period.
The stock was up 21.9% at $54.55 at press time, according to data from Benzinga Pro.
Photo: PublicDomainPictures from Pixabay.
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