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 (APLS) announced the appointment of Caroline Baumal, M.D., as the new chief medical officer, replacing Federico Grossi, M.D., Ph.D., who will assist during the transition until February 28, 2023. Dr. Baumal brings over 25 years of experience in retina research and patient care, crucial for the upcoming launch of pegcetacoplan for geographic atrophy (GA). The company is preparing for a PDUFA date next month, with pegcetacoplan showing promise in clinical trials as the first treatment for GA, a leading cause of blindness affecting millions.
Apellis Pharmaceuticals (Nasdaq: APLS) will present at the 41st Annual J.P. Morgan Healthcare Conference on January 9, 2023, at 9:00 a.m. PT / 12:00 p.m. ET. The event will be available via a live webcast on the company’s website, with a replay accessible for 90 days post-event. Apellis is recognized for pioneering complement medicine, having launched the first approved targeted C3 therapy, and is focused on developing transformative treatments for rare retinal and neurological diseases.
Apellis Pharmaceuticals (Nasdaq: APLS) has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency for pegcetacoplan, targeting geographic atrophy (GA) due to age-related macular degeneration (AMD). This application is based on Phase 3 DERBY and OAKS trials, showing significant reductions in GA lesion growth over 24 months. If approved, pegcetacoplan would be the first treatment for GA in Europe. The FDA review is pending with a PDUFA date of February 26, 2023, highlighting the urgency for treatment in a disease that severely impacts more than five million globally.
Apellis Pharmaceuticals (Nasdaq: APLS) recently announced the approval of equity inducement awards for two new employees, effective December 1, 2022. The awards include options to purchase 8,790 restricted stock units (RSUs), which will vest annually at 25% over four years, contingent on the employees' continued employment. This move aligns with Nasdaq Listing Rule 5635(c)(4) and is aimed at attracting talent by offering competitive compensation through equity opportunities. Apellis remains committed to advancing innovative therapies in complement medicine.
Apellis Pharmaceuticals (Nasdaq: APLS) has announced its participation in two upcoming investor conferences. The first is the 5th Annual Evercore ISI HealthCONx Conference, featuring a fireside chat scheduled for November 29, 2022, at 8:25 a.m. ET. The second is the Bank of America 2022 Virtual Biotech SMID Cap Conference, set for December 7, 2022, at 9:40 a.m. ET. Both events will be accessible via live webcast on the company's website, with replays available for 90 days.
Apellis Pharmaceuticals (Nasdaq: APLS) announced that the FDA accepted its unsolicited amendment to the New Drug Application (NDA) for intravitreal pegcetacoplan, aimed at treating geographic atrophy (GA) due to age-related macular degeneration (AMD). The new PDUFA goal date is set for February 26, 2023. The FDA also stated no advisory committee meeting will occur. The 24-month clinical data from Phase 3 studies DERBY and OAKS was included, suggesting a strong product profile with efficacy and safety. Apellis plans to submit an EU marketing application by the end of 2022.
Apellis Pharmaceuticals (APLS) reported Q3 2022 net product revenues of $17.7 million from EMPAVELI, contributing to total revenues of $22.1 million. The company plans to submit 24-month Phase 3 efficacy data for intravitreal pegcetacoplan for geographic atrophy (GA) to the FDA, with a PDUFA target action date set for February 2023. Cash and investments reached $708.6 million, providing a strong cash runway into Q1 2024. R&D expenses increased to $95.2 million. Despite a net loss of $191.3 million, Apellis continues to advance its product pipeline.
On November 4, 2022, Apellis Pharmaceuticals (Nasdaq: APLS) announced the approval of equity awards for 7 new employees as part of their 2022 Inducement Stock Incentive Plan. A total of 20,375 restricted stock units (RSUs) were granted, with 25% vesting after one year and the remainder vesting annually, dependent on continued employment. This initiative aligns with Nasdaq Listing Rule 5635(c)(4) and supports the company's growth strategy in the biopharmaceutical sector.
Apellis Pharmaceuticals (APLS) has announced plans to submit 24-month efficacy data from the Phase 3 DERBY and OAKS studies as part of its New Drug Application (NDA) for intravitreal pegcetacoplan, targeting geographic atrophy (GA) related to age-related macular degeneration (AMD). This submission will be a Major Amendment, extending the review period by three months with a new PDUFA target action date of February 2023. The company anticipates that these long-term data will strengthen the product profile at launch with minimal impact on the launch timeline originally scheduled for January.
Apellis Pharmaceuticals announced positive results from its long-term extension study of EMPAVELI (pegcetacoplan) for treating adults with paroxysmal nocturnal hemoglobinuria (PNH). The study, to be presented at the ASH Annual Meeting on Dec. 10, shows sustained improvements over two years, with mean hemoglobin levels at 11.6 g/dl, 83% of patients transfusion-free, and 73% achieving normalized lactate dehydrogenase levels. The therapy demonstrated efficacy in both treatment-naïve and previously treated patients, with no new safety concerns reported.