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) reported Q2 2025 financial results, highlighting significant achievements including FDA approval of EMPAVELI for C3G and IC-MPGN treatment. The company generated $178.5 million in total revenue, with SYFOVRE contributing $150.6 million in U.S. net product sales.
Key developments include a $300 million royalty purchase agreement with Sobi for 90% of ex-U.S. EMPAVELI royalties and continued market leadership of SYFOVRE in GA treatment with 60% market share. The company reported a net loss of $42.2 million and cash position of $370 million, which combined with expected revenues and Sobi agreement funds, is anticipated to sustain operations until profitability.
Apellis Pharmaceuticals (Nasdaq: APLS) has received FDA approval for EMPAVELI® (pegcetacoplan) as the first treatment for C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN) in patients 12 years and older.
The approval is based on the Phase 3 VALIANT study results showing three key achievements: a 68% reduction in proteinuria (p<0.0001), stabilization of kidney function (p=0.03), and substantial clearance of C3 deposits, with 71% of treated patients achieving complete clearance.
This breakthrough treatment targets rare kidney diseases affecting 5,000 people in the United States, where approximately 50% of patients progress to kidney failure within 5-10 years of diagnosis. The therapy demonstrated efficacy across both adolescent and adult patients, including those with post-transplant disease recurrence.
Apellis Pharmaceuticals (Nasdaq: APLS) announced it will host a conference call and webcast to discuss its second quarter 2025 financial results on Thursday, July 31, 2025, at 8:30 a.m. ET.
Investors can pre-register for the call, and a live audio webcast with accompanying slides will be available through the company's website. The webcast replay will be accessible for 90 days after the event.
Apellis Pharmaceuticals (Nasdaq: APLS) announced that five abstracts highlighting SYFOVRE® (pegcetacoplan injection) data have been accepted for oral presentation at the American Society of Retina Specialists (ASRS) Annual Scientific Meeting from July 30 - August 2 in Long Beach, California.
The presentations will showcase SYFOVRE's efficacy and safety profile in treating geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The data demonstrates SYFOVRE's ability to slow GA progression with as few as six doses per year. The abstracts cover various aspects including baseline characteristics, early vs. delayed treatment results, clinical utility in bilateral GA, combination therapy with anti-VEGF treatments, and the impact of AREDS supplements on GA progression.
SYFOVRE is notable as the first-ever approved therapy for GA, a condition affecting over one million Americans and five million people worldwide.
Apellis Pharmaceuticals (Nasdaq: APLS) has entered into a significant royalty purchase agreement with Sobi® worth up to $300 million for Aspaveli® (systemic pegcetacoplan). The deal includes $275 million upfront and potential $25 million in milestone payments tied to EMA approval for C3G and IC-MPGN indications.
Under the agreement, Sobi will acquire 90% of Apellis' ex-U.S. royalties for Aspaveli, with royalty rates ranging from high teens to high twenties. Apellis maintains exclusive U.S. commercialization rights, where the product is marketed as EMPAVELI®. The agreement includes performance-based caps, after which all ex-U.S. royalties will revert to Apellis.
Aspaveli/EMPAVELI is currently approved for paroxysmal nocturnal hemoglobinuria (PNH) treatment in the EU, U.S., and other countries. The drug is under regulatory review for C3 glomerulopathy (C3G) and IC-MPGN treatment, with an expected CHMP opinion before year-end and a PDUFA date of July 28, 2025.
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.
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