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, Inc. (Nasdaq:APLS) announced on July 27, 2022, the completion of privately negotiated exchange agreements involving its 3.500% Convertible Senior Notes due 2026. Approximately $65.9 million of these Notes will be exchanged for 2,036,886 shares of common stock, while another $9.7 million will be swapped for additional shares based on a calculated valuation. The transactions are set to close by August 1, 2022, contingent on customary conditions. Notably, the shares issued will not be registered under the Securities Act, limiting their sale.
Apellis Pharmaceuticals (Nasdaq: APLS) announced that the FDA has accepted its New Drug Application (NDA) for pegcetacoplan, a targeted C3 therapy for the treatment of geographic atrophy (GA) due to age-related macular degeneration (AMD). The PDUFA target action date is set for November 26, 2022. This application has been granted a Priority Review designation, highlighting its potential as a breakthrough treatment. The submission is based on data from the Phase 2 FILLY and Phase 3 DERBY and OAKS studies, involving over 1,500 patients, showing clinically meaningful results and a favorable safety profile.
Apellis Pharmaceuticals (Nasdaq: APLS) announced significant new data from Phase 3 studies at the American Society of Retina Specialists Annual Meeting. The results support the efficacy of pegcetacoplan in slowing lesion growth in geographic atrophy (GA) associated with age-related macular degeneration (AMD). The company submitted a New Drug Application to the FDA in June 2022, with a decision on acceptance expected in August 2022. Pegcetacoplan has no current approved treatments for GA, highlighting an urgent need for effective therapies for this debilitating condition.
Apellis Pharmaceuticals (Nasdaq: APLS) announced the grant of equity awards to six new employees, effective July 1, 2022. This grant comprised options to purchase 20,295 restricted stock units (RSUs), which will vest 25% annually over four years, contingent on the employees' continued employment. This equity inducement aligns with Nasdaq Listing Rule 5635(c)(4) and aims to facilitate employee recruitment and retention. Apellis continues to focus on delivering innovative therapies in complement medicine and advancing treatments for rare diseases.
Apellis Pharmaceuticals (Nasdaq: APLS) has expanded its R&D collaboration with Affilogic to include Nanofitins® targeting the transferrin receptor (TfR), facilitating drug delivery across the blood-brain barrier. This partnership aims to develop brain-active C3 inhibitors to treat neurodegenerative diseases by combining technologies. Apellis also plans to submit IND applications for two promising candidates: APL-1030 for neurodegenerative conditions and APL-2006 for age-related macular degeneration. The agreement grants Apellis exclusive patent rights for all development projects.
Apellis Pharmaceuticals (APLS) and Sobi announced new analyses of Phase 3 studies on EMPAVELI (pegcetacoplan) for paroxysmal nocturnal hemoglobinuria (PNH), revealing its efficacy and safety. The results indicate significant quality of life improvements for treatment-naïve patients and comparable thrombosis rates to eculizumab. Additionally, a matching-adjusted indirect comparison (MAIC) showed better clinical outcomes for EMPAVELI compared to C5 inhibitors. These findings are set to be presented at the European Hematology Association Congress in Vienna.
Apellis Pharmaceuticals (APLS) and Sobi have commenced the Phase 3 VALIANT study for pegcetacoplan, targeting primary immune-complex membranoproliferative glomerulonephritis (IC-MPGN) and C3 glomerulopathy (C3G). This study addresses a significant unmet need, as these rare conditions currently lack approved treatments. The trial involves approximately 90 patients aged 12 and older, with a primary endpoint of achieving at least a 50% reduction in urine protein-to-creatinine ratio after 26 weeks. The results of this study could have substantial implications for patient care and market potential.
Apellis Pharmaceuticals (Nasdaq: APLS) announced the approval of equity inducement awards for thirteen new employees, effective June 1, 2022. These awards included options to purchase 55,900 shares and 72,711 restricted stock units (RSUs). The options were granted at an exercise price of $41.35, matching the stock's closing price on the grant date. Vesting will occur over four years for options and annually for RSUs, contingent on continued employment. This initiative aligns with Nasdaq Listing Rules, supporting talent acquisition in the competitive biopharmaceutical sector.
Apellis Pharmaceuticals (Nasdaq: APLS) announced its participation in two major investor conferences in June 2022. The Jefferies Healthcare Conference features a fireside chat on June 9, 2022, at 4:30 p.m. ET, while the Goldman Sachs 43rd Annual Global Healthcare Conference will take place on June 15, 2022, at 9:20 a.m. PT. Both events will be available via live webcast and can be accessed from the company's website. Following the events, webcasts will be replayable for 90 days.
Apellis Pharmaceuticals (APLS) announced the submission of a New Drug Application (NDA) to the FDA for pegcetacoplan, targeting geographic atrophy (GA) secondary to age-related macular degeneration (AMD). GA affects over 5 million people worldwide, with no current approved treatments. Pegcetacoplan has shown promise in reducing GA lesion growth in Phase 3 studies, DERBY and OAKS, as well as the Phase 2 FILLY study. The FDA is expected to respond to the NDA by August 2022.
FAQ
What is the current stock price of Apellis Pharmace (APLS)?
What is the market cap of Apellis Pharmace (APLS)?
