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. reports news on its commercial-stage biopharmaceutical business centered on complement science and C3-targeting medicines. Recurring updates cover SYFOVRE, a pegcetacoplan injection for geographic atrophy secondary to age-related macular degeneration, and EMPAVELI, pegcetacoplan for rare diseases including paroxysmal nocturnal hemoglobinuria and rare kidney indications.
Company news also includes product revenue updates, ophthalmology and nephrology data presentations, pipeline references tied to complement biology, board and governance changes, investor conference participation, collaboration matters, and corporate-status developments involving strategic transactions and related shareholder communications.
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.
On January 26, 2021, Apellis Pharmaceuticals (Nasdaq:APLS) announced the successful completion of privately negotiated exchange transactions involving its 3.500% Convertible Senior Notes due 2026. Holders exchanged approximately $126.1 million of the Notes for 3,906,869 shares of common stock.
The shares issued are not registered under the Securities Act of 1933 and cannot be sold in the U.S. without proper registration or an exemption. Apellis remains focused on developing therapies for diseases linked to the complement cascade.