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) is a commercial-stage biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapeutic compounds. The company's primary focus is on treating diseases with high unmet medical needs through the inhibition of the complement system, a crucial part of the immune system. Apellis targets the complement system at the level of C3, aiming to provide comprehensive disease control.
Apellis's flagship products include SYFOVRE® (pegcetacoplan injection) and EMPAVELI® (pegcetacoplan). SYFOVRE is the first-ever approved therapy for geographic atrophy (GA), a leading cause of blindness, while EMPAVELI is approved for treating paroxysmal nocturnal hemoglobinuria (PNH), a rare hematological disease. Both medicines reflect the company's innovative approach to complement immunotherapy.
In 2023, Apellis achieved significant milestones, including generating $397 million in revenue, with substantial contributions from SYFOVRE and EMPAVELI. The company has also presented positive data from its Phase 2 NOBLE study for systemic pegcetacoplan in rare kidney diseases at the European Renal Association Congress, highlighting the potential of pegcetacoplan to address complex medical conditions.
Looking ahead, Apellis anticipates regulatory developments, including the European Medicines Agency’s (EMA) review of the marketing authorization application (MAA) for SYFOVRE and the expected topline data from the Phase 3 VALIANT study of systemic pegcetacoplan in mid-2024. Financially robust, Apellis recently closed a $375 million funding deal with Sixth Street to buy out existing liabilities, significantly improving its liquidity profile and positioning the company for sustainable growth.
Apellis's commitment to advancing science is evident through its extensive pipeline and collaborations, such as its partnership with Sobi for systemic pegcetacoplan. The company's approach combines bold scientific endeavors with compassionate patient care, continually striving to bring life-changing therapies to those in need.
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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