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 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.
Apellis Pharmaceuticals (Nasdaq: APLS) has announced its participation in the Jefferies London Healthcare Conference. The company will host a fireside chat on Tuesday, November 19, 2024, at 8:30 a.m. GMT. The event will be accessible through a live webcast on the company's website under the 'Events and Presentations' page in the 'Investors and Media' section. Interested parties can access a replay of the webcast, which will remain available for approximately 90 days after the event.
Apellis Pharmaceuticals reported Q3 2024 financial results with total revenue of $196.8 million, including $176.6 million in U.S. net product sales. SYFOVRE demand grew 7% quarter-over-quarter, generating $152.0 million in U.S. net product revenue, though sales were impacted by higher gross-to-net adjustments. EMPAVELI contributed $24.6 million in U.S. net product revenue. The company reported a net loss of $57.4 million and held cash and equivalents of $396.9 million as of September 30, 2024. Following FDA feedback, Apellis plans to file an sNDA for pegcetacoplan in C3G/IC-MPGN in early 2025.
Apellis Pharmaceuticals (APLS) announced positive Phase 3 VALIANT study results for pegcetacoplan in treating C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN). The study demonstrated a statistically significant 68% proteinuria reduction compared to placebo. Key secondary endpoints showed pegcetacoplan stabilized kidney function (eGFR) with a +6.3mL/min/1.73m2 difference over placebo, and 71% of treated patients achieved complete clearance of C3c deposits. The treatment demonstrated a favorable safety profile, with similar adverse event rates between treatment and placebo groups. Apellis plans FDA submission in early 2025.
Apellis Pharmaceuticals (Nasdaq: APLS) has announced it will host a conference call and webcast on November 5, 2024, at 8:30 a.m. ET to discuss its third quarter 2024 financial results. Interested parties can pre-register for the call, and a live audio webcast with accompanying slides will be accessible through the company's website. A replay of the webcast will be available for 90 days following the event.
Apellis is a global biopharmaceutical company focused on developing life-changing therapies for challenging diseases. They have introduced the first new class of complement medicine in 15 years and currently have two approved medicines targeting C3, including the first-ever therapy for geographic atrophy, a leading cause of blindness worldwide. The company aims to further explore the potential of targeting C3 across various retinal, rare, and neurological diseases.
Apellis Pharmaceuticals (Nasdaq: APLS) announced that the abstract of the Phase 3 VALIANT study of pegcetacoplan in C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN) was accepted for oral presentation at the American Society of Nephrology (ASN) Kidney Week. The presentation will take place on October 26 at 11:00 a.m. PT in San Diego, CA.
Following the presentation, Apellis will host a webinar at 12:30 p.m. PT to discuss the detailed VALIANT results. Two additional abstracts on pegcetacoplan in C3G and primary IC-MPGN were accepted as poster presentations, focusing on post-transplant recurrent cases and long-term safety and efficacy.