Business
Apellis Pharmaceuticals Reports Third Quarter 2021 Financial Results
Generated $5.3 million in EMPAVELI™ (pegcetacoplan) net product revenues Presented Phase 3 DERBY and OAKS results in geographic atrophy (GA); on track for NDA
About this update from Apellis Pharmaceuticals, Inc.
[{"type":"text","content":"Generated $5.3 million in EMPAVELI™ (pegcetacoplan) net product revenues Presented Phase 3 DERBY and OAKS results in geographic atrophy (GA); on track for NDA submission in 1H 2022Received positive CHMP opinion for pegcetacoplan for treatment of PNH; expect decision regarding approval by European Commission by end of 2021 Conference call scheduled today at 4:30 p.m. ET WALTHAM, Mass., Nov. 08, 2021 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS), a global biopharmaceutical company and leader in complement, today announced its third quarter 2021 financial results and business highlights. “The third quarter was another exceptional period for Apellis, highlighted by successful commercial execution with EMPAVELI in PNH, the Phase 3 DERBY and OAKS results in geographic atrophy, and continued momentum advancing our broader pipeline,” said Cedric Francois, M.D., Ph.D., co-founder and chief executive officer of Apellis. “Our commercial launch of EMPAVELI is off to a strong start in the U.S. and we expect a decision regarding approval by the European Commission by the end of this year as we seek to elevate the standard of care in PNH worldwide.” Dr. Francois continued, “With the DERBY and OAKS data, intravitreal pegcetacoplan has the potential to become the first treatment for patients living with geographic atrophy, a leading cause of blindness worldwide. We believe we have a robust data package that supports approval and remain on track to submit our New Drug Application to the FDA in the first half of 2022. Behind our lead programs, we are continuing to progress our broad pipeline addressing complement-driven diseases in rare disease, neurology, and ophthalmology.” Third Quarter 2021 Business Highlights and Upcoming Milestones: Paroxysmal Nocturnal Hemoglobinuria (PNH) Commercial Progress Apellis recorded $5.3 million in EMPAVELI™ (pegcetacoplan) net product revenue for the third quarter of 2021.In October 2021, Apellis and Sobi announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) had adopted a positive opinion recommending the marketing authorization of systemic pegcetacoplan for the treatment of adults with PNH who are anemic after treatment with a C5 inhibitor for at least three months. A decision regarding approval is expected by the European Commission by...