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. (APLS) is a leader in developing transformative therapies targeting the complement system, with approved treatments for geographic atrophy and rare blood disorders. This page provides investors and researchers with essential updates on the company’s progress in retinal, hematologic, and renal disease innovation.
Access timely announcements including FDA decisions, clinical trial results, and strategic partnerships that demonstrate Apellis’ commitment to advancing complement immunotherapy. Our curated news collection covers critical developments such as SYFOVRE’s commercial adoption, EMPAVELI’s clinical applications, and research collaborations expanding therapeutic pipelines.
Key updates include regulatory milestones in ophthalmology, hematology treatment expansions, and nephrology research advancements. Bookmark this page to stay informed about Apellis’ pioneering work in C3-targeted therapies and its impact on addressing diseases with limited treatment options.
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.
Apellis Pharmaceuticals (APLS) and Sobi announced that the European Medicines Agency (EMA) has validated an indication extension application for Aspaveli® (pegcetacoplan) to treat C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN), rare kidney diseases currently without approved treatments.
The application is supported by positive Phase 3 VALIANT study results, which showed a significant 68% reduction in proteinuria (p<0.0001) in pegcetacoplan-treated patients versus placebo at Week 26. The treatment demonstrated consistent results across subgroups, achieved kidney function stabilization (p=0.03), and showed reduced C3c staining intensity (p<0.0001). The safety profile remained favorable and consistent with previous findings.
If approved, pegcetacoplan could potentially launch in the U.S. for C3G and IC-MPGN in the second half of 2025.
Apellis Pharmaceuticals (APLS) has announced it will host a conference call and webcast to discuss its fourth quarter and full year 2024 financial results on Friday, February 28, 2025, at 8:30 a.m. ET. Interested participants must pre-register to access the live call.
The company will provide a live audio webcast with accompanying slides through the 'Events and Presentations' page on their website's 'Investors and Media' section. The webcast replay will be available for 90 days after the event.
Apellis Pharmaceuticals (Nasdaq: APLS) has announced the approval of equity inducement awards for three new employees, effective February 3, 2025. The grants, made outside the company's 2017 Stock Incentive Plan but under the 2020 Inducement Stock Incentive Plan, consist of 7,805 restricted stock units (RSUs). These equity awards were approved in compliance with Nasdaq Listing Rule 5635(c)(4).
The RSUs will vest over four years, with 25% vesting on the first anniversary of the grant date and an additional 25% vesting annually thereafter, contingent upon continued employment.
Apellis Pharmaceuticals (APLS) has received approval from Australia's Therapeutic Goods Administration (TGA) for SYFOVRE® (pegcetacoplan) to treat geographic atrophy (GA) in adults. SYFOVRE becomes the first and only approved treatment for GA in Australia, where over 75,000 people are affected by this condition.
The treatment is specifically approved for adult patients with GA secondary to age-related macular degeneration (AMD) with an intact fovea, particularly when central vision is threatened by GA lesion growth. The approval is based on Phase 3 OAKS and DERBY studies results at 24 months, which demonstrated that both monthly and every-other-month SYFOVRE treatments effectively slowed GA progression with a generally well-tolerated safety profile.
GA is a progressive and irreversible disease that leads to blindness by destroying retinal cells responsible for vision. The condition significantly impacts patients' independence and quality of life, affecting their ability to read, drive, and recognize faces.
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