Why Apellis Pharmaceuticals (APLS) Shares Are Falling Today - Apellis Pharmaceuticals (NASDAQ:APLS)

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.

Why Are Apellis Pharmaceuticals Shares Falling Today?