- FDA pushed back their decision date for Apellis Pharmaceuticals Inc's APLS pegcetacoplan for geographic atrophy (GA) secondary to age-related macular degeneration (AMD) from November 26 to sometime next February.
- The move comes after Apellis said it would submit two-year efficacy data from a pair of Phase 3 studies this month, additions the agency considers a "major amendment."
- The FDA accepted the application under priority review status.
- Long-term data released this past March raised expectations, as pegcetacoplan appeared to remain durable after 18 months — both in patients dosed monthly and once every two months.
- Apellis remains on track to submit a European marketing application, including the 24-month results, by the end of 2022.
- The drug is already approved for the rare disease paroxysmal nocturnal hemoglobinuria (PNH) and is marketed as Empaveli. In this space, Apellis has positioned its product as a challenger to AstraZeneca Plc's AZN C5 inhibitors Soliris and follow-up drug Ultomiris.
- Price Action: APLS shares are down 20.80% at $47.56 on the last check Friday.
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