Business
Apellis Pharmaceuticals Reports Third Quarter 2022 Financial Results
Plans to submit 24-month Phase 3 data to the FDA for intravitreal pegcetacoplan for geographic atrophy (GA); expected PDUFA target action date in February
About this update from Apellis Pharmaceuticals, Inc.
[{"type":"text","content":"Plans to submit 24-month Phase 3 data to the FDA for intravitreal pegcetacoplan for geographic atrophy (GA); expected PDUFA target action date in February 2023EU marketing authorization application submission on track for December 2022Reported 24-month data with pegcetacoplan in GA showing increased effects over time and continued favorable safety profileAchieved $17.7 million in Q3 2022 EMPAVELI® (pegcetacoplan) U.S. net product revenuesCash and investments of $708.6 million as of Sept. 30, 2022; expected cash runway into Q1 2024Conference call scheduled today at 4:30 p.m. ET WALTHAM, Mass., Nov. 07, 2022 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS), a global biopharmaceutical company and leader in complement, today announced its third quarter 2022 financial results and business highlights. “We are making strong progress across the organization, including preparing for the potential approval and launch of intravitreal pegcetacoplan in GA. We believe that our recent decision to add the 24-month efficacy data to our NDA gives us the opportunity to have the best product profile at launch, with minimal impact to launch timing,” said Cedric Francois, M.D., Ph.D., co-founder and chief executive officer of Apellis. “At 24 months, both every-other-month and monthly pegcetacoplan demonstrated robust and increasing effects over time, with remarkable consistency across the two studies.” Dr. Francois continued, “Additionally, the commercialization of our first product, EMPAVELI, continues to help more and more people living with PNH in its second year of launch. We also continue to progress EMPAVELI in a broad range of debilitating, rare diseases, with four later-stage clinical programs underway.” Third Quarter 2022 Business Highlights and Upcoming Milestones: Paroxysmal Nocturnal Hemoglobinuria (PNH) Commercial Progress Apellis recorded $17.7 million in EMPAVELI® (pegcetacoplan) U.S. net product revenues.The Prescription Drug User Fee Act (PDUFA) target action date for the supplemental New Drug Application (sNDA) with the Phase 3 PRINCE results and the 48-week Phase 3 PEGASUS data is in February 2023.Apellis will be presenting long-term data reinforcing the robust efficacy and safety profile of EMPAVELI in patients with PNH at the 2022 American Society of Hematology (ASH) Annual Meeting being held December 10-13, 2022,...