Apellis Pharmaceuticals, Inc. - APLS STOCK NEWS

Apellis Pharmaceuticals (APLS) announced that the FDA accepted its New Drug Application (NDA) for pegcetacoplan, targeting paroxysmal nocturnal hemoglobinuria (PNH), and granted Priority Review. The PDUFA action date is set for May 14, 2021. The FDA will not hold an advisory committee meeting to discuss the application. Pegcetacoplan showed superiority over eculizumab in the Phase 3 PEGASUS study, enhancing hemoglobin levels significantly. Apellis plans to initiate an early access program in the U.S. for patients with ongoing disease activity despite C5 inhibition.

Apellis Pharmaceuticals (APLS) announced findings from a major retrospective study on geographic atrophy (GA) secondary to age-related macular degeneration (AMD), presented at the AAO 2020. Involving over 69,000 patients, the data reveal significant disease progression, with up to 21.6% of bilateral GA patients developing new-onset wet AMD in 24 months. The study emphasizes the pressing need for effective treatment for GA, which affects five million people globally. Currently, there are no approved therapies for GA, although Apellis is advancing pegcetacoplan in Phase 3 studies.

Apellis Pharmaceuticals (Nasdaq: APLS) announced its participation in two key investor conferences this November. The company will present at the Stifel 2020 Virtual Healthcare Conference on November 18 at 10:00 a.m. ET and at the Jefferies Virtual London Healthcare Conference on November 19 at 6:45 a.m. ET. CEO Cedric Francois will partake in a fireside chat and a podium presentation, respectively. Both events will be webcast live and available for replay for 90 days. Apellis focuses on developing innovative therapies for diseases involving the complement cascade.

Apellis Pharmaceuticals (Nasdaq: APLS) announced that eight abstracts highlighting the efficacy of pegcetacoplan for treating paroxysmal nocturnal hemoglobinuria (PNH) have been accepted for the virtual American Society of Hematology Annual Meeting from December 5-8, 2020. New analyses from the Phase 3 PEGASUS study show superior treatment response and quality-of-life improvements with pegcetacoplan compared to eculizumab. The matching-adjusted indirect comparison indicated notable enhancements in clinical outcomes when compared to ravulizumab, demonstrating pegcetacoplan's potential to redefine PNH care standards.

Apellis Pharmaceuticals announces a collaboration with Sobi for the co-development and ex-U.S. commercialization of systemic pegcetacoplan, potentially worth $1.25 billion. The EMA validated the marketing authorization application for pegcetacoplan in PNH. Key trial results include a 52% reduction in lesion growth in geographic atrophy patients and a 73.3% reduction in proteinuria in C3G patients. As of September 30, 2020, Apellis has $728.2 million in cash, supporting operations through 2022 despite a net loss of $135.7 million in Q3 2020.

Apellis Pharmaceuticals and Sobi have entered a strategic collaboration for the global co-development and exclusive ex-U.S. commercialization of systemic pegcetacoplan, a targeted C3 therapy. Apellis retains U.S. rights and global rights for ophthalmological pegcetacoplan. Sobi will pay an upfront fee of $250 million, with up to $915 million in milestones and royalties. The partnership aims to advance systemic pegcetacoplan in five registrational programs, targeting diseases in hematology, nephrology, and neurology, with pivotal studies slated to begin in 2021.

Apellis Pharmaceuticals (APLS) has released 18-month data from the Phase 1b APL2-103 study, demonstrating that intravitreal pegcetacoplan effectively slows the growth of geographic atrophy (GA) lesions. The post hoc analysis of seven patients exhibited a 52% reduction in lesion growth in the treated eye compared to the untreated eye. With no reported inflammation and only one case of new-onset exudation, the results indicate the safety of pegcetacoplan. Top-line data from the ongoing Phase 3 DERBY and OAKS studies are expected in Q3 2021.

Apellis Pharmaceuticals (APLS) announced results from a 41-patient observational study showing that elevated systemic levels of C3a correlate with COVID-19 severity. In a Phase 1/2 interventional study, initial safety results from six patients indicate APL-9, a targeted C3 therapy, may improve outcomes in severe cases. Key findings include that 97.5% of patients had significantly high C3a levels, averaging 3.7 times the upper limit of normal. An independent committee recommended continuing the investigation of APL-9, which is currently enrolling 60 more patients.

Apellis Pharmaceuticals (Nasdaq: APLS) announced positive results from the Phase 2 DISCOVERY study on pegcetacoplan for C3 glomerulopathy (C3G). Patients exhibited a mean reduction of over 65% in proteinuria after 48 weeks, a key indicator of kidney damage. The study included eight C3G patients, where one showed a 73.3% decrease in proteinuria, alongside improvements in serum albumin and renal function. No severe adverse events were recorded, demonstrating the treatment's potential for this rare disease without approved therapies.