Business
Apellis Pharmaceuticals Reports Fourth Quarter and Full Year 2022 Financial Results
SYFOVRE™ (pegcetacoplan injection) approved in the U.S. as the first and only treatment for geographic atrophy (GA) secondary to age-related macular
About this update from Apellis Pharmaceuticals, Inc.
[{"type":"text","content":"SYFOVRE™ (pegcetacoplan injection) approved in the U.S. as the first and only treatment for geographic atrophy (GA) secondary to age-related macular degeneration (AMD)EU marketing authorization application for intravitreal pegcetacoplan validated by the European Medicines Agency; decision by European Commission (EC) expected in early 2024 EMPAVELI® (pegcetacoplan) sNDA approved including Phase 3 PRINCE data and 48-week Phase 3 PEGASUS dataGenerated $65.1 million in full year 2022 EMPAVELI U.S. net product revenues WALTHAM, Mass., Feb. 21, 2023 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS), a global biopharmaceutical company and leader in complement, today announced its fourth quarter and full year 2022 financial results and business highlights. “2022 was another year of remarkable execution for Apellis as we moved closer toward our goal of bringing SYFOVRE to patients with GA worldwide and continued to elevate the standard of care in PNH with EMPAVELI. Last week, we were thrilled to announce the FDA approval of SYFOVRE as the first and only treatment approved for patients living with GA, and we are now ready to launch in the U.S.,” said Cedric Francois, M.D., Ph.D., co-founder and chief executive officer of Apellis. “With two commercial products, a robust pipeline of multiple late-stage programs, and a portfolio of pre-clinical assets heading towards the clinic, we believe we are in a strong position for 2023 and beyond.” Dr. Francois continued, “With our first two approvals in less than two years, we believe we have only begun to unlock the potential of targeting C3 to treat some of the most challenging diseases that patients face. We look forward to building on this momentum.” Fourth Quarter and Full Year 2022 Business Highlights and Upcoming Milestones: Ophthalmology Highlights SYFOVRE for the treatment of GA secondary to AMD: On February 17, 2023, the FDA approved SYFOVRE for the treatment of GA secondary to AMD. Apellis expects the commercial launch of SYFOVRE by the beginning of March 2023.A marketing authorization application for intravitreal pegcetacoplan was validated and is currently under review by the European Medicines Agency with an EC decision expected in early 2024.Apellis also submitted a New Drug Submission for SYFOVRE to Health Canada and expects to submit applications in Switzerland, Austra...