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 (Nasdaq: APLS) announced that NEJM published positive Phase 3 VALIANT results for EMPAVELI (pegcetacoplan) in C3 glomerulopathy (C3G) and primary IC-MPGN at Week 26.
Key results: 68% proteinuria reduction versus placebo (p<0.0001); eGFR stabilization +6.3 mL/min/1.73 m2 versus placebo (nominal p=0.03); and 71% of treated patients achieved zero C3 staining. EMPAVELI showed a favorable safety profile consistent with prior experience and was FDA-approved July 28, 2025.
Apellis Pharmaceuticals (Nasdaq: APLS) announced management will participate in webcast fireside chats at two investor conferences: Citi 2025 Global Healthcare Conference on December 2, 2025 at 2:30 p.m. ET and Evercore 8th Annual Healthcare Conference on December 3, 2025 at 2:10 p.m. ET.
Live webcasts will be posted on the company’s Investors and Media > Events and Presentations webpage. A replay will be available for approximately 30 days after each event.
Apellis (Nasdaq: APLS) reported five-year post hoc GALE data showing continuous treatment with SYFOVRE (pegcetacoplan) delayed geographic atrophy (GA) lesion growth by approximately 1.5 years versus sham/projected sham in patients with nonsubfoveal GA. Both monthly and every-other-month dosing regimens showed similar delay. The safety profile through five years remained consistent with prior reports. Detailed results will be presented at a future medical meeting.
Apellis Pharmaceuticals (Nasdaq: APLS) will present at the Stifel 2025 Healthcare Conference on Wednesday, November 12, 2025 at 2:40 p.m. ET. The company said a live webcast will be posted on the Events and Presentations page of its Investors and Media website. A replay of the webcast will be available for approximately 90 days after the event.
Apellis (Nasdaq: APLS) reported third quarter 2025 results on October 30, 2025, with $458.6 million total revenue including a $275.0 million upfront from Sobi for a capped ex-U.S. royalty purchase on Aspaveli. Product sales included $150.9 million for SYFOVRE and $26.8 million for EMPAVELI in the U.S. EMPAVELI received FDA approval July 28, 2025 for C3G and primary IC-MPGN (12+), with launch activity showing 152 patient start forms by Sept 30, 2025.
SYFOVRE delivered ~101K doses (including ~15K free goods), total injections grew 4% QoQ, and SYFOVRE market share remained above an estimated 60%. Cash and equivalents were $479.2 million at Sept 30, 2025. Management expects existing cash plus product revenues to fund operations to sustainable profitability.
Apellis Pharmaceuticals (NASDAQ: APLS) announced new one-year Phase 3 VALIANT data for EMPAVELI (pegcetacoplan) in C3 glomerulopathy (C3G) and primary IC-MPGN presented at ASN Kidney Week on October 20, 2025. Key results: EMPAVELI sustained a 68% proteinuria reduction versus placebo (p<0.0001) at one year, with consistent effects irrespective of immunosuppressant use or baseline proteinuria. One-third of treated patients achieved complete proteinuria remission (UPCR ≤0.5 g/g) versus 3% on placebo at Week 26, maintained through one year. EMPAVELI stabilized eGFR and showed a safety profile consistent with prior data. Two anchored indirect treatment comparisons indicated EMPAVELI was superior to iptacopan on multiple proteinuria and composite renal endpoints, with noted methodological limitations for ITCs.
Apellis (Nasdaq: APLS) will host a conference call and webcast to discuss third quarter 2025 financial results on Thursday, October 30, 2025 at 8:30 a.m. ET.
Investors can pre-register to join by phone, and a live audio webcast plus slides will be available on the company’s Investors and Media "Events and Presentations" page. A replay of the webcast will be accessible for 90 days after the event.
Apellis describes itself as a global biopharmaceutical company focused on complement science with two C3-targeting medicines approved for four diseases; contact for investor inquiries is Eva Stroynowski at the company.
Apellis Pharmaceuticals (Nasdaq: APLS) announced its participation in three upcoming investor conferences in September 2025. The company's management will engage in webcast fireside chats at the Wells Fargo Healthcare Conference (September 3 at 8:45 a.m. ET), Cantor Global Healthcare Conference (September 4 at 8:35 a.m. ET), and Baird Global Healthcare Conference (September 9 at 10:15 a.m. ET).
All webcasts will be accessible through the company's website under the "Events and Presentations" page, with replays available for approximately 30 days after each event.
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 (p0.0001), 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.