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) announced the acceptance of 10 abstracts for presentation at the ARVO Annual Meeting from May 1-7, 2021. Key highlights include five oral presentations showcasing the potential of pegcetacoplan, an investigational C3 therapy, targeting geographic atrophy (GA). The presentations emphasize AI analytics for monitoring GA lesions and new safety and efficacy data from the Phase 2 FILLY study. Pegcetacoplan has received Fast Track designation for GA and is being evaluated across various clinical studies.
Apellis Pharmaceuticals (APLS) announced promising results from the Phase 1b APL2-103 study of pegcetacoplan, showing a 46% reduction in mean lesion growth in patients with geographic atrophy after 24 months (p=0.007). The study involved 12 patients, and data from eight patients demonstrated significant efficacy compared to untreated eyes. No significant inflammation was reported, with only 16% developing new onset exudation. The company expects top-line results from pivotal Phase 3 DERBY and OAKS studies in Q3 2021 and plans to invite participants from the 1b study to a long-term extension study.
Apellis Pharmaceuticals (APLS) announced that pegcetacoplan, a targeted C3 therapy, outperformed eculizumab in the Phase 3 PEGASUS study for treating paroxysmal nocturnal hemoglobinuria (PNH). The study demonstrated a statistically significant increase in hemoglobin levels of 3.8 g/dL (p0.001) at 16 weeks. Additionally, 85% of patients receiving pegcetacoplan were transfusion-free compared to 15% with eculizumab. Marketing applications for pegcetacoplan are under Priority Review by the FDA, with a target action date of May 14, 2021, and are also under review by the EMA.
Apellis Pharmaceuticals (APLS) announced the publication of post hoc analyses from the Phase 2 FILLY study, validating the efficacy of pegcetacoplan, a C3 therapy for geographic atrophy (GA) secondary to AMD. The articles, featured in Ophthalmology and the American Journal of Ophthalmology, confirm consistent results across patient subgroups, indicating a significant unmet need in GA treatment, which currently lacks approved therapies. With over 1,200 patients enrolled in ongoing Phase 3 studies, Apellis aims to provide a breakthrough solution for approximately five million GA patients globally.
Apellis Pharmaceuticals (Nasdaq: APLS) announced the approval of equity awards for two new employees on March 1, 2021. The grants, consisting of options for 33,650 shares and 825 restricted stock units (RSUs), are part of the 2021 Inducement Stock Incentive Plan. The options have an exercise price of $47.68, matching the closing price on the grant date. Vesting is structured over four years, with a quarterly vesting schedule for options and annual vesting for RSUs. This move aligns with Nasdaq Listing Rule 5635(c)(4) and aims to enhance talent acquisition.
Apellis Pharmaceuticals (Nasdaq: APLS) announced it will cease further development of APL-9 for severe COVID-19 treatment. This decision follows an interim review by an independent data monitoring committee (DMC), which revealed no significant reduction in mortality rates in patients receiving APL-9 alongside standard care compared to those receiving standard care alone. However, the DMC reported no safety concerns. Full results will be shared at a scientific forum after data analysis.
Apellis Pharmaceuticals (APLS) announced its fourth quarter and full year 2020 financial results, revealing a net income of $78.3 million for Q4, compared to a net loss of $113.2 million in 2019. As of December 31, 2020, cash and investments totaled $877.6 million, supporting operations into late 2022. The FDA has accepted the NDA for pegcetacoplan for PNH with a PDUFA date of May 14, 2021. Positive Phase 3 data for pegcetacoplan indicates significant treatment benefits. Upcoming milestones include Phase 3 results for geographic atrophy expected in Q3 2021.
Apellis Pharmaceuticals (Nasdaq: APLS) announced its participation in three investor conferences in March 2021. The Raymond James 42nd Annual Institutional Investors Conference will feature a fireside chat on March 1 at 9:10 a.m. ET. The Cowen 41st Annual Health Care Conference will include a New Drug Launches panel on March 3 at 10:20 a.m. ET, while the Oppenheimer 31st Annual Healthcare Conference will host another fireside chat on March 17 at 8:40 a.m. ET. Webcasts will be available live and on a 90-day replay via the company’s website.
Apellis Pharmaceuticals (APLS) announced it will hold a conference call on February 25, 2021, at 4:30 p.m. ET to discuss its fourth quarter and full year 2020 financial results. Interested participants can join the call by dialing (866) 774-0323 for domestic access or (602) 563-8683 for international access, using conference ID # 6956712. A webcast of the event will also be accessible via the company’s website, where a replay will be available for 90 days.
Apellis focuses on developing targeted C3 therapies for various diseases.
Apellis Pharmaceuticals (Nasdaq: APLS) announced the approval of equity awards for 14 new employees, effective February 1, 2021, as part of their 2021 Inducement Stock Incentive Plan. This includes options to purchase 56,500 shares and 13,275 restricted stock units (RSUs) at an exercise price of $44.20, reflecting the common stock's closing price on the grant date. The options will vest over four years, while the RSUs will vest similar to the options. This move aims to attract talent critical to the company’s growth in targeted C3 therapies.