Welcome to our dedicated page for Apellis Pharmace news (Ticker: APLS), a resource for investors and traders seeking the latest updates and insights on Apellis Pharmace stock.
Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) generates frequent news as a commercial-stage biopharmaceutical company focused on C3 complement science. Its updates often center on the performance and expansion of its approved C3-targeting medicines, SYFOVRE for geographic atrophy (GA) secondary to age-related macular degeneration and EMPAVELI/Aspaveli for complement-mediated rare diseases such as C3 glomerulopathy (C3G), primary IC-MPGN, and paroxysmal nocturnal hemoglobinuria (PNH).
Investors following APLS news can expect regular disclosures on commercial execution, including U.S. net product revenues, patient start forms, market share in GA, and payer coverage trends in C3G and primary IC-MPGN. Apellis also issues news on long-term clinical data, such as five-year GALE extension results for SYFOVRE and one-year VALIANT data for EMPAVELI, which highlight durability of treatment effect and safety profiles.
Another major category of Apellis news involves clinical and regulatory milestones. Releases cover Phase 2 and Phase 3 trial progress, pivotal trial initiations in new nephrology indications like focal segmental glomerulosclerosis and delayed graft function, regulatory approvals, and opinion timelines from agencies such as the U.S. Food and Drug Administration and the European Medicines Agency. The company also announces publication of key data in peer-reviewed journals, including The New England Journal of Medicine.
Corporate and financial communications are a further news stream, including quarterly financial results, cash and cash equivalents updates, royalty and collaboration agreements with partners such as Sobi, and participation in major healthcare and investor conferences. For readers tracking APLS, this news page provides a centralized view of Apellis’ commercial performance, pipeline evolution, regulatory events, and strategic transactions related to its complement-based therapies.
Apellis Pharmaceuticals has initiated a Phase 1/2 clinical study of APL-9, a novel C3 inhibitor, targeting COVID-19 patients experiencing respiratory failure, including ARDS. This trial follows preliminary evidence showing complement activation is significantly elevated in COVID-19-related ARDS. The study will enroll 66 patients and aims to assess APL-9's safety alongside standard care, with secondary objectives related to hospital stay duration and survival rates. The FDA has expedited the review of APL-9, which may control the complement cascade and improve outcomes in severe COVID-19 cases.
Apellis Pharmaceuticals (APLS) plans to submit a New Drug Application (NDA) for pegcetacoplan targeting paroxysmal nocturnal hemoglobinuria (PNH) in H2 2020, following a successful pre-NDA meeting with the FDA. The NDA will include results from the Phase 3 PEGASUS trial, which demonstrated pegcetacoplan's superiority over eculizumab in improving hemoglobin levels. The study's safety profile was comparable to that of eculizumab. Regulatory discussions with EU authorities are also set for Q2 2020, as Apellis aims to further develop pegcetacoplan for PNH and other conditions.
Apellis Pharmaceuticals announced positive results from its Phase 3 PEGASUS study, demonstrating that pegcetacoplan significantly improved hemoglobin levels in patients with paroxysmal nocturnal hemoglobinuria (PNH) compared to eculizumab. This pivotal study was selected for an oral presentation at the 25th European Hematology Association Congress, validating the innovative research and commitment to improve standards of care for PNH patients. Pegcetacoplan has received Fast Track designation from the FDA for treating PNH and is also being evaluated for other conditions.
Apellis Pharmaceuticals (Nasdaq: APLS) announced its participation at the BofA Securities 2020 Health Care Conference on May 14, 2020, at 8:20 a.m. ET. The event will take place virtually, featuring a fireside chat with CEO Cedric Francois. The discussion will be accessible via a live webcast on the company’s Investors and Media page. Following the event, a replay will be available for 90 days. Apellis focuses on developing targeted C3 therapies for diseases caused by excessive complement activation.
Apellis Pharmaceuticals (Nasdaq: APLS) announced equity awards granted to three new employees as an inducement for their acceptance of employment. The awards include options to purchase a total of 112,526 shares, with exercise prices set at $32.02 and $34.11 for options granted on May 1 and May 4, 2020, respectively. The options will vest over four years, contingent on continued employment with the company. This grant was consistent with Nasdaq Listing Rule 5635(c)(4) and was approved in earlier months prior to the awards.
Apellis Pharmaceuticals (Nasdaq: APLS) announced a $300 million private placement of 3.500% convertible senior notes due 2026, with an aggregate purchase price of $328.9 million. The deal closing is expected on May 12, 2020. The notes will be unsecured senior obligations, maturing on September 15, 2026, with an initial conversion rate of 25.3405 shares per $1,000 principal amount. Net proceeds of approximately $323 million will fund clinical development of pegcetacoplan and support commercialization efforts.
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