Welcome to our dedicated page for Apellis Pharmaceuticals news (Ticker: APLS), a resource for investors and traders seeking the latest updates and insights on Apellis Pharmaceuticals 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) 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 (p<0.001) 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.
On January 21, 2021, Apellis Pharmaceuticals (NASDAQ: APLS) announced a virtual investor event titled Pegcetacoplan: Advancing the First Potential Treatment for Geographic Atrophy, scheduled for January 28, 2021. This event will highlight the unmet needs in Geographic Atrophy (GA) and discuss the intravitreal pegcetacoplan program, which is expected to yield Phase 3 GA results in Q3 2021. Renowned retinal specialists will participate, and the live webcast will be available on their website. A replay will be accessible for 90 days post-event.
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