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 (APLS) has announced a conference call and webcast set for November 8, 2021, at 4:30 p.m. ET to discuss its third quarter 2021 financial results. Interested participants can register for the call via a provided link, with conference ID 1931859. The event will also be accessible through a live audio webcast on the company’s website, with a replay available for 90 days afterward. Apellis is known for its commitment to developing targeted C3 therapies aimed at debilitating diseases across multiple medical fields, including hematology and ophthalmology.
Apellis Pharmaceuticals (APLS) and Sobi have announced a positive opinion from the European Medicines Agency's CHMP for Aspaveli® (pegcetacoplan) to treat adults with paroxysmal nocturnal hemoglobinuria (PNH) who remain anemic after at least three months on a C5 inhibitor. This recommendation is now forwarded to the European Commission for review. Aspaveli aims to provide a new treatment option for the approximately 72% of patients still anemic after C5 therapy. This follows recent U.S. approval for the same indication, which could significantly impact treatment paradigms for PNH in Europe.
Apellis Pharmaceuticals (APLS) announced the grant of equity awards to three new employees, effective October 1, 2021. The awards include options for 32,000 shares and 1,000 restricted stock units (RSUs), with an exercise price of $33.59, matching the stock's closing price on the grant date. The options will vest over four years, while the RSUs will vest 25% annually. This action, aligned with Nasdaq Listing Rule 5635(c)(4), is a strategic move to attract talent critical for the company's growth in targeted C3 therapies.
Apellis Pharmaceuticals (APLS) presented Phase 3 study results for pegcetacoplan, a targeted C3 therapy, at the Retina Society Annual Scientific Meeting. The OAKS trial showed significant reduction in geographic atrophy (GA) lesion growth with monthly (p=0.0003) and every-other-month (p=0.0052) treatments. The DERBY trial showed a reduction in lesion growth but narrowly missed the primary endpoint. Pegcetacoplan could become the first treatment for GA, which affects over five million globally. An NDA is planned for submission in H1 2022.
Apellis Pharmaceuticals (Nasdaq: APLS) announced its participation in the 2021 Cantor Virtual Global Healthcare Conference, scheduled for September 27, 2021, at 8:40 a.m. ET. The conference will be conducted virtually and accessible via a live webcast on the company’s website. A replay will be available for 90 days post-event. Apellis, a leader in targeted C3 therapies, focuses on transformative solutions for diseases caused by complement cascade activation.
Apellis Pharmaceuticals, Inc. (APLS) announced positive results from the Phase 3 DERBY and OAKS studies evaluating intravitreal pegcetacoplan for geographic atrophy (GA) due to age-related macular degeneration (AMD). In the OAKS study, pegcetacoplan achieved its primary endpoint, reducing GA lesion growth by 22% (p=0.0003) monthly and 16% (p=0.0052) every-other-month. Conversely, DERBY did not meet its primary endpoint, exhibiting lesser reductions. Overall, pegcetacoplan demonstrated a 26% reduction in lesion growth among patients with extrafoveal lesions. Aiming for FDA approval, Apellis plans to submit a New Drug Application in early 2022.
Apellis Pharmaceuticals (Nasdaq: APLS) announced the grant of equity awards to a new employee effective September 1, 2021, as part of their 2021 Inducement Stock Incentive Plan. The awarded equity includes options to purchase 1,000 shares at an exercise price of $64.73, the closing price on the grant date, and 500 restricted stock units (RSUs). The options will vest over four years, while the RSUs will vest annually over four years, contingent on continued employment. This move aims to incentivize talent acquisition in line with Nasdaq Listing Rule 5635(c)(4).
On September 3, 2021, Apellis Pharmaceuticals (Nasdaq: APLS) announced the approval of equity awards for Jim Chopas, its newly appointed VP, Corporate Controller / Chief Accounting Officer. The award includes options to purchase 21,750 shares at an exercise price of $65.41, equal to the stock's closing price on the grant date. Additionally, 7,600 restricted stock units (RSUs) were granted. The vesting schedule for both options and RSUs is contingent on Chopas' continued employment with the company. This appointment aligns with Nasdaq Listing Rule 5635(c)(4).
Apellis Pharmaceuticals (APLS) received FDA approval for EMPAVELI™, the first targeted C3 therapy for adults with paroxysmal nocturnal hemoglobinuria (PNH), and initiated a U.S. commercial launch. The company reported $0.6 million in net product revenue for Q2 2021, marking its first sales since EMPAVELI's approval. Additionally, positive results were announced from the Phase 3 PRINCE study, indicating statistical superiority in key endpoints. Apellis continues to expand its pipeline and has entered into a collaboration with Beam Therapeutics for new therapies.
Apellis Pharmaceuticals (Nasdaq: APLS) announced on August 6, 2021, that it approved equity awards for three new employees. The awards consist of options to purchase 75,100 shares and 5,050 restricted stock units (RSUs), granted under the 2021 Inducement Stock Incentive Plan. The options have an exercise price of $63.25, equal to the stock's closing price on the grant date. The vesting schedule includes a one-year cliff and monthly vesting thereafter for options, while RSUs vest 25% annually. This move aims to attract talent to support growth and innovation.