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 (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.
Apellis Pharmaceuticals (APLS) reported preliminary full-year 2024 U.S. net product revenues of $709 million, with SYFOVRE generating $611 million and EMPAVELI contributing $98 million. SYFOVRE, their market-leading treatment for geographic atrophy, saw over 120% year-over-year net sales growth with more than 510,000 injections administered.
The company maintains a strong financial position with approximately $410 million in cash at year-end 2024. They expect to submit an sNDA for EMPAVELI in C3G and primary IC-MPGN in early 2025, with U.S. launch anticipated in 2H 2025. Additionally, Phase 3 studies for two nephrology indications are planned for 2H 2025.
Organizational changes include COO Adam Townsend's departure in February 2025, with David Acheson named as executive vice president of commercial. The company plans to reduce its ex-U.S. footprint by approximately 40 employees while prioritizing U.S. commercial efforts.
Apellis Pharmaceuticals (NASDAQ: APLS) has announced the immediate appointment of Keli Walbert to its Board of Directors, expanding the board to seven members, with six being independent. Walbert brings over 20 years of biopharmaceutical commercial leadership experience, most recently serving as executive vice president of U.S. commercial at Horizon Therapeutics.
In her previous role, Walbert oversaw commercial strategy for more than 10 marketed brands across various therapeutic areas including nephrology, ophthalmology, and rare diseases. She notably led the launch of TEPEZZA, a blockbuster medicine for thyroid eye disease. Her prior experience includes leadership positions at AbbVie, American Medical Association, Abbott, and United Healthcare.
Walbert's appointment aims to strengthen Apellis's commercial expertise as the company continues to expand its geographic atrophy treatment reach and prepares for potential launches in C3G and IC-MPGN indications.
Apellis Pharmaceuticals (Nasdaq: APLS) has announced the approval of equity inducement awards for one new employee, granted on January 2, 2025. The awards, consisting of 4,135 restricted stock units (RSUs), were granted outside the company's 2017 Stock Incentive Plan but under the 2020 Inducement Stock Incentive Plan. The RSUs will vest over four years, with 25% vesting on the first anniversary of the grant date and an additional 25% annually thereafter, contingent on continued employment. The grants were approved in compliance with Nasdaq Listing Rule 5635(c)(4).
Apellis Pharmaceuticals (Nasdaq: APLS) has announced its upcoming presentation at the 43rd Annual J.P. Morgan Healthcare Conference. The presentation is scheduled for Monday, January 13, 2025, at 9:45 a.m. PT.
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. For those unable to attend live, a replay of the webcast will remain available for approximately 90 days after the event.
Apellis Pharmaceuticals (Nasdaq: APLS) has granted equity inducement awards to four new employees effective December 2, 2024. The awards, approved under Nasdaq Listing Rule 5635(c)(4), include:
- Options to purchase 27,445 shares at $35.42 per share (closing price on grant date)
- 28,630 restricted stock units (RSUs)
The stock options will vest 25% after one year, followed by monthly vesting of 1/48th of shares over four years. RSUs will vest 25% annually over four years. All vestings are subject to continued employment.
Apellis Pharmaceuticals (Nasdaq: APLS) has announced its participation in two major investor conferences in December 2024. The company will present at the Evercore ISI HealthCONx Conference on December 4 at 9:10 a.m. ET and the Citi Global Healthcare Conference on December 5 at 1:00 p.m. ET. Both fireside chat sessions will be available via webcast on the company's website under the 'Events and Presentations' page, with replays accessible for approximately 90 days after the events.
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