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 (NASDAQ: APLS) has announced its participation in two upcoming investor conferences in May 2025. The company will participate in a fireside chat at the BofA Securities 2025 Healthcare Conference on May 13 at 8:40 a.m. PT, and another fireside chat at the Stifel 2025 Virtual Ophthalmology Forum on May 27 at 2:30 p.m. ET. Both events will be webcast live and available on the company's website under the \"Events and Presentations\" page, with replays accessible for approximately 90 days after the events.
Apellis Pharmaceuticals (Nasdaq: APLS) has scheduled its first quarter 2025 financial results conference call and webcast for May 7, 2025, at 8:30 a.m. ET. Investors can pre-register for the phone call, while a live audio webcast with accompanying slides will be available through the company's website under "Events and Presentations" in the "Investors and Media" section.
Apellis positions itself as a global biopharmaceutical leader that combines scientific innovation with patient care. The company has achieved significant milestones, including:
- Introduction of the first new complement medicine class in 15 years
- Two approved medicines targeting C3
- Development of the first-ever therapy for geographic atrophy, a major cause of blindness globally
The webcast replay will be accessible for 90 days after the event. Investor relations contact is available through Neil Carnahan.
Apellis Pharmaceuticals (APLS) has announced the immediate appointment of Craig Wheeler to its Board of Directors. Wheeler, currently founder and CEO of Headwaters Biotech Advisors, brings over 30 years of biopharmaceutical leadership experience.
Wheeler's notable experience includes a 14-year tenure as president and CEO of Momenta Pharmaceuticals, leading the company through multiple product launches until its acquisition by Johnson and Johnson in 2020. He also served as president of Chiron Biopharmaceuticals, managing a global unit of 2,500 employees.
Currently serving on the Board of Directors of Amicus Therapeutics, Wheeler holds an MBA from the Wharton School and both BS and MS degrees in Chemical Engineering from Cornell University.
Apellis Pharmaceuticals (APLS) announced FDA acceptance and Priority Review designation for EMPAVELI® (pegcetacoplan) supplemental New Drug Application (sNDA) for treating C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN), rare kidney diseases. The PDUFA target date is set for July 28, 2025.
The submission is supported by positive Phase 3 VALIANT study results, which showed:
- 68% reduction in proteinuria compared to placebo (p<0.0001)
- Stabilization of kidney function measured by eGFR (p=0.03)
- 71% of treated patients achieved complete clearance of C3c staining
Results were consistent across C3G and IC-MPGN patients, including adolescents, adults, and those with native and post-transplant kidney disease. The treatment demonstrated favorable safety and tolerability.
Cardurion Pharmaceuticals has appointed Karen Lewis as Chief People Officer, bringing over 25 years of human resources experience to the clinical-stage biotechnology company. Lewis joins from Apellis Pharmaceuticals (APLS), where she served as Chief People Officer and led organizational growth from 200 to over 900 employees globally while supporting the launch of two drug products.
Prior to Apellis, Lewis held leadership positions at Axcella Health, Biogen (BIIB), Amazon, and Bristol-Myers Squibb (BMY). At Biogen, she served as Vice President of Global Talent Acquisition and headed HR for U.S. commercial and Asia Pacific/Latin America operations. Lewis holds a B.S. in biology from Rider University and began her career as a research scientist before transitioning to HR.
Apellis Pharmaceuticals (APLS) reported strong financial results for FY2024, with total revenue reaching $781.4 million, representing 97% year-over-year growth. The company's flagship products showed robust performance: SYFOVRE® generated $611.9 million in net product revenue, while EMPAVELI® contributed $98.1 million.
Key highlights include the submission of a supplemental new drug application for EMPAVELI in C3G and IC-MPGN, with anticipated U.S. launch in H2 2025. The company delivered approximately 94,000 SYFOVRE doses in Q4 2024, with over 510,000 injections administered since launch. The company reported a significantly reduced net loss of $197.9 million for FY2024, compared to $528.6 million in 2023.
With $411.3 million in cash and cash equivalents as of December 31, 2024, combined with expected product revenues, Apellis anticipates sufficient funding to reach profitability.
Apellis Pharmaceuticals (Nasdaq: APLS) has announced its upcoming participation at the TD Cowen 45th Annual Health Care Conference. The presentation is scheduled for Monday, March 3, 2025, at 10:30 a.m. ET.
The company will provide a live webcast of the conference presentation, which will be accessible through the 'Events and Presentations' page in the 'Investors and Media' section of Apellis' website. Interested parties who cannot attend the live presentation will have access to a replay of the webcast for approximately 90 days after the event.