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 (Nasdaq: APLS) has successfully closed privately negotiated exchange transactions for its 3.500% Convertible Senior Notes due 2026. Approximately $201.1 million of these notes were exchanged, resulting in the issuance of 5,992,217 shares of common stock. The shares are unregistered under current securities laws and cannot be sold in the U.S. without proper registration or exemption. This strategic move aims to strengthen the company's financial position and support its ongoing commitment to developing targeted C3 therapies for various debilitating diseases.
Apellis Pharmaceuticals (Nasdaq:APLS) announced it has engaged in privately negotiated exchange agreements with holders of its 3.500% Convertible Senior Notes due 2026. The holders have agreed to exchange approximately $198.6 million of the Notes for 4,530,431 shares of common stock, equating to 22.8065 shares per $1,000 of Notes. An additional number of shares will be issued based on the average stock price over a specified period. The exchange transactions are expected to close by July 23, 2021, pending customary closing conditions.
Apellis Pharmaceuticals (APLS) announced equity awards to a new employee, consisting of options for 8,000 shares and 4,000 restricted stock units (RSUs). The options have an exercise price of $67.80, matching the closing stock price on the grant date of July 1, 2021. The vesting schedule sets forth that one-fourth of the options will vest after one year, with the remainder vesting monthly over four years. This grant aligns with Nasdaq Listing Rule 5635(c)(4) and supports the company’s efforts in attracting talent for its targeted C3 therapies.
Apellis Pharmaceuticals (Nasdaq: APLS) and Beam Therapeutics (Nasdaq: BEAM) announced a five-year exclusive collaboration focused on base editing technology to develop treatments for complement-driven diseases. The partnership will target six research programs directed at the eye, liver, and brain, utilizing Beam's technology for precision gene editing. Apellis will lead the development of licensed programs and has committed $75 million, with further milestone payments possible. This strategic alliance aims to enhance Apellis' leadership in complement therapeutics and expand treatment options for patients.
Apellis Pharmaceuticals (Nasdaq: APLS) will host a Research and Development Day on June 30, 2021, from 12:30 p.m. to 4:30 p.m. ET in New York City and online. The event will showcase the company’s expanding pipeline in rare diseases, ophthalmology, and neurology. Key opinion leaders from top institutions will participate, including experts from Fondazione IRCCS and the Montreal Neurological Institute. A live webcast and presentation will be available on Apellis’ website, with a replay accessible for 90 days post-event.
Apellis Pharmaceuticals (Nasdaq: APLS) announced its participation in two upcoming investor conferences. The Goldman Sachs Healthcare Conference will feature a fireside chat on June 10, 2021 at 8:00 a.m. ET, while the Bank of America Napa Biopharma Conference is set for June 16, 2021 at 4:30 p.m. ET. Both events will be available via live webcast and can be accessed from the company’s investors and media page. Replays will be accessible for 90 days post-event.
Apellis focuses on pioneering targeted C3 therapies for various diseases.
Apellis Pharmaceuticals (APLS) reported positive results from the Phase 3 PRINCE study of EMPAVELI™ (pegcetacoplan) for treating paroxysmal nocturnal hemoglobinuria (PNH) in treatment-naïve adults. The study showed statistical superiority in hemoglobin stabilization (86% vs. 0%, p<0.0001) and significant reduction in lactate dehydrogenase (90% decrease) compared to standard care. Mean hemoglobin levels rose from 9.4 to 12.1 g/dL in the EMPAVELI group. Additionally, 91% of EMPAVELI patients remained transfusion-free. The safety profile was consistent with previous studies, with serious adverse events being lower than standard care.
Apellis Pharmaceuticals announced FDA approval of EMPAVELI™ (pegcetacoplan), a groundbreaking targeted C3 therapy for adults with paroxysmal nocturnal hemoglobinuria (PNH). This therapy is approved for treatment-naïve patients and those switching from C5 inhibitors like Soliris® and Ultomiris®. In the pivotal Phase 3 PEGASUS study, EMPAVELI demonstrated superiority over Soliris in increasing hemoglobin levels and a significant 85% of EMPAVELI patients were transfusion-free at Week 16. However, EMPAVELI carries a boxed warning for serious infections, necessitating vaccinations before treatment.
Apellis Pharmaceuticals (Nasdaq: APLS) announced the acceptance of seven abstracts for the European Hematology Association (EHA) Virtual Congress from June 9-17, 2021, showcasing the potential of pegcetacoplan, a targeted C3 therapy, for paroxysmal nocturnal hemoglobinuria (PNH). An oral presentation and e-posters emphasize pegcetacoplan's efficacy and safety. The FDA has set a target action date of May 14, 2021, for its marketing application.
Apellis Pharmaceuticals (Nasdaq: APLS) announced the grant of equity awards to two new employees on May 3, 2021. The grant includes options for 13,200 shares at an exercise price of $50.20 and 7,100 restricted stock units (RSUs). The equity awards aim to incentivize new hires as part of the company's 2020 Inducement Stock Incentive Plan. Shares from the options will vest over four years, while RSUs will vest 25% annually. This move is compliant with Nasdaq Listing Rule 5635(c)(4).
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