Apellis Pharmace (APLS) Stock News

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 (APLS) and Sobi presented promising one-year data from the Phase 3 VALIANT study of EMPAVELI (pegcetacoplan) for treating C3G and primary IC-MPGN kidney diseases. The study demonstrated sustained efficacy with a significant 68% proteinuria reduction versus placebo at Week 26, maintained through one year. Patients showed stable kidney function measured by eGFR, with similar benefits observed in patients who switched from placebo to EMPAVELI. The drug maintained a favorable safety profile with no new safety signals. The data, presented at the ERA Congress, supports pending marketing applications under review with FDA and EMA, with an FDA decision expected this summer.

Apellis Pharmaceuticals (APLS) has announced its participation in the upcoming Goldman Sachs 46th Annual Global Healthcare Conference. The company's presentation is scheduled for Wednesday, June 11, 2025, at 10:40 a.m. ET. Investors and interested parties can access the live webcast through the 'Events and Presentations' page in the 'Investors and Media' section of Apellis' website. A replay of the presentation will remain available for approximately 90 days after the event.

Apellis Pharmaceuticals (APLS) reported Q1 2025 financial results with total revenue of $166.8 million, down from $172.3 million in Q1 2024. SYFOVRE U.S. net product sales were $130.2 million, with injection demand growing 4% QoQ despite revenue impacts from inventory dynamics and co-pay assistance program funding shortages. EMPAVELI generated $19.7 million in U.S. net product revenue. The company reported a net loss of $92.2 million, compared to $66.4 million in Q1 2024. With $358.4 million in cash as of March 31, 2025, Apellis expects combined cash and future sales to fund operations to profitability. The FDA accepted their sNDA for EMPAVELI with Priority Review for C3G and IC-MPGN treatment, with a decision expected in July 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.

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 (p0.0001)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.