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.
On November 4, 2022, Apellis Pharmaceuticals (Nasdaq: APLS) announced the approval of equity awards for 7 new employees as part of their 2022 Inducement Stock Incentive Plan. A total of 20,375 restricted stock units (RSUs) were granted, with 25% vesting after one year and the remainder vesting annually, dependent on continued employment. This initiative aligns with Nasdaq Listing Rule 5635(c)(4) and supports the company's growth strategy in the biopharmaceutical sector.
Apellis Pharmaceuticals (APLS) has announced plans to submit 24-month efficacy data from the Phase 3 DERBY and OAKS studies as part of its New Drug Application (NDA) for intravitreal pegcetacoplan, targeting geographic atrophy (GA) related to age-related macular degeneration (AMD). This submission will be a Major Amendment, extending the review period by three months with a new PDUFA target action date of February 2023. The company anticipates that these long-term data will strengthen the product profile at launch with minimal impact on the launch timeline originally scheduled for January.
Apellis Pharmaceuticals announced positive results from its long-term extension study of EMPAVELI (pegcetacoplan) for treating adults with paroxysmal nocturnal hemoglobinuria (PNH). The study, to be presented at the ASH Annual Meeting on Dec. 10, shows sustained improvements over two years, with mean hemoglobin levels at 11.6 g/dl, 83% of patients transfusion-free, and 73% achieving normalized lactate dehydrogenase levels. The therapy demonstrated efficacy in both treatment-naïve and previously treated patients, with no new safety concerns reported.
Apellis Pharmaceuticals (APLS) has announced a conference call scheduled for November 7, 2022, at 4:30 p.m. ET to discuss its third quarter 2022 financial results. The live call will be accessible via phone and through a webcast available on the company's website. The firm is recognized for pioneering the first new class of complement medicine in 15 years, aiming to develop transformative therapies for rare, retinal, and neurological diseases. Further information on the event and the company can be found on their official website.
Apellis Pharmaceuticals (Nasdaq: APLS) has granted equity awards to 8 new employees as equity inducement awards under the 2022 Inducement Stock Incentive Plan. The awards were approved on October 3, 2022, in compliance with Nasdaq Listing Rule 5635(c)(4). Each employee received options to purchase 38,840 restricted stock units (RSUs), which will vest annually over four years, contingent on continued employment. This move is part of Apellis' strategy to attract talent and enhance its strong position in the biopharmaceutical industry, particularly in complement medicine.
Apellis Pharmaceuticals announced promising results from the 24-month Phase 3 OAKS study of pegcetacoplan for treating geographic atrophy (GA) related to age-related macular degeneration (AMD). New analyses revealed that patients receiving pegcetacoplan treatments, both monthly and every-other-month, exhibited improved visual function near GA lesion borders compared to sham treatments. The data supports pegcetacoplan's potential as the first effective therapy for GA, aiming for regulatory submissions to the European Medicines Agency and a PDUFA target action date of November 26, 2022, in the U.S.
Apellis Pharmaceuticals (APLS) announced four oral presentations at the AAO Annual Meeting regarding pegcetacoplan for treating geographic atrophy (GA) due to age-related macular degeneration. The presentations will cover 24-month safety and efficacy results from Phase 3 DERBY and OAKS studies. The FDA has granted Priority Review for pegcetacoplan, with a target action date of November 26, 2022. The company plans to submit a marketing authorization application to the European Medicines Agency by year-end.
Apellis Pharmaceuticals (Nasdaq: APLS) announced an updated timing for its fireside chat at the Bank of America Global Healthcare Conference. The chat is scheduled for September 16, 2022, at 9:55 a.m. BST / 4:55 a.m. ET. This event will be accessible via a live webcast on the company's website. Apellis is recognized for its innovative work in complement medicine, having introduced the first targeted C3 therapy in 15 years to treat rare, retinal, and neurological diseases.
Apellis Pharmaceuticals announced the approval of equity awards for 64 new employees on September 1, 2022. The awards consist of options for 12,500 shares and 113,372 restricted stock units (RSUs). The options have an exercise price of $63.58, the closing price on the grant date. Vesting for the options occurs over four years, while RSUs vest at 25% annually. These grants are part of Apellis' 2022 Inducement Stock Incentive Plan and are crucial for employee retention. This announcement signifies Apellis' commitment to recruiting top talent in the biopharmaceutical sector.
Apellis Pharmaceuticals (Nasdaq: APLS) will participate in several investor conferences in September 2022. Notable events include the Citi 17th Annual BioPharma Conference on September 7 at 1:00 p.m. ET, the Wells Fargo Healthcare Conference on September 8 at 1:55 p.m. ET, the Baird 2022 Global Healthcare Conference on September 14 at 3:10 p.m. ET, and the BofA Global Research Healthcare Conference on September 16 at 10:05 a.m. ET. Webcasts will be available on their website for 30 days post-event.
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