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Release Details Apellis Pharmaceuticals Reports Second Quarter 2021 Financial Results August 9 , 2021 _ • Received approval for EMPAVELI ™ ( pegcetacoplan ) – the first targeted C3 therapy - from U.S. Food • and Drug Administration ( FDA ) for treatment of adults with paroxysmal nocturnal hemoglobinuria ( PNH ) and launched in U.S. Reported positive top - line results from Phase 3 PRINCE study of EMPAVELI in treatment - naïve patients with PNH • Established exclusive research collaboration with Beam Therapeutics to apply base editing to discover novel therapies for complement - driven diseases . • Expect top - line results from Phase 3 geographic atrophy ( GA ) studies in September 2021 Conference call scheduled today at 4:30 p.m. ET WALTHAM , Mass . , Aug. 09 , 2021 ( GLOBE NEWSWIRE ) -- , Inc. ( Nasdaq : APLS ) , a global biopharmaceutical company and leader in targeted C3 therapies , today announced its second quarter 2021 financial results and business highlights . “ The second quarter was an exceptional period for Apellis , underscored by the approval of EMPAVELI – the first FDA - approved targeted C3 therapy for adults with PNH and a strong start to our U.S. commercial launch . We and our partner Sobi were also thrilled to report positive data from our Phase 3 PRINCE study in treatment - naïve PNH patients , emphasizing the potential for EMPAVELI to redefine treatment for all adults with PNH , " said Cedric Francois M.D. , Ph.D. , co - founder and chief executive officer of Apellis . " We are looking forward to the Phase 3 DERBY and OAKS readouts in September . GA is a leading cause of blindness worldwide , and we are excited about the potential to bring the first treatment to the millions of patients affected by this disease . " " In addition to the broad platform potential of our targeted C3 therapy , our world - class research team is advancing multiple new molecular entities across several modalities , and we entered an exclusive collaboration with Beam Therapeutics to discover transformative therapies using its base editing technology . With our expanded pipeline across rare disease , ophthalmology , and neurology , we believe we are well positioned for long - term , global leadership in complement , ” Dr. Francois continued . Second Quarter 2021 Business Highlights and Upcoming Milestones : Rare Disease • In May 2021 , Apellis that the FDA approved EMPAVELI for the treatment of adults with PNH including patients who are treatment naïve , as well as patients switching from the C5 inhibitors Soliris® ( eculizumab ) and Ultomiris® ( ravulizumab ) . • EMPAVELI is available commercially in the United States . Apellis recorded $ 0.6 million in net product revenue for the second quarter of 2021 , which reflects recorded sales of EMPAVELI upon approval by the FDA in May 2021 through June 30 , 2021. Apellis did not have any net product revenue in the quarter ended June 30 , 2020 . • A decision on the Marketing Authorization Application is expected by the European Commission in the second half of 2021 . * May 2021 , Apellis and Sobi positive top - line results from the Phase 3 PRINCE study evaluating the efficacy and safety of EMPAVELI in adults with PNH who are treatment naïve . EMPAVELI