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) announced an investor conference call for June 12, 2020, to discuss detailed results from the Phase 3 PEGASUS study of pegcetacoplan (APL-2) against eculizumab for paroxysmal nocturnal hemoglobinuria (PNH). This comes ahead of its presentation at the 25th Annual Congress of the European Hematology Association. The call will feature Apellis management and key study investigator Peter Hillmen, providing insights into the study's findings and future implications.
Apellis Pharmaceuticals (Nasdaq: APLS) has announced the grant of equity awards to four new employees, effective June 1, 2020. This grant is part of the 2020 Inducement Stock Incentive Plan, with the options to purchase 37,800 shares at an exercise price of $34.01. The awards will vest over four years, with a quarter vesting after one year and the remainder monthly thereafter. Additionally, the company highlights its commitment to advancing targeted C3 therapies for severe diseases.
Apellis Pharmaceuticals (Nasdaq: APLS) will present at the Goldman Sachs 41st Annual Global Healthcare Conference on June 11, 2020, at 1:20 p.m. ET. The presentation will feature a fireside chat with co-founder and CEO Cedric Francois, M.D., Ph.D. The event is set to take place virtually and can be accessed live via the company's website. A replay of the webcast will be available for 90 days post-event. Apellis focuses on pioneering targeted C3 therapies aimed at treating debilitating diseases arising from excessive activation of the complement cascade.
Apellis Pharmaceuticals (Nasdaq: APLS) has granted an equity inducement award to a new employee, comprising an option to purchase 23,216 shares of common stock at an exercise price of $33.94, equal to the stock's closing price on the grant date, May 26, 2020. The award was approved on April 30, 2020, in compliance with Nasdaq Listing Rule 5635(c)(4). The shares will vest over four years, with one-fourth vesting on the one-year employment anniversary and the remainder vesting monthly thereafter.
Apellis Pharmaceuticals has initiated a Phase 1/2 clinical study of APL-9, a novel C3 inhibitor, targeting COVID-19 patients experiencing respiratory failure, including ARDS. This trial follows preliminary evidence showing complement activation is significantly elevated in COVID-19-related ARDS. The study will enroll 66 patients and aims to assess APL-9's safety alongside standard care, with secondary objectives related to hospital stay duration and survival rates. The FDA has expedited the review of APL-9, which may control the complement cascade and improve outcomes in severe COVID-19 cases.
Apellis Pharmaceuticals (APLS) plans to submit a New Drug Application (NDA) for pegcetacoplan targeting paroxysmal nocturnal hemoglobinuria (PNH) in H2 2020, following a successful pre-NDA meeting with the FDA. The NDA will include results from the Phase 3 PEGASUS trial, which demonstrated pegcetacoplan's superiority over eculizumab in improving hemoglobin levels. The study's safety profile was comparable to that of eculizumab. Regulatory discussions with EU authorities are also set for Q2 2020, as Apellis aims to further develop pegcetacoplan for PNH and other conditions.
Apellis Pharmaceuticals announced positive results from its Phase 3 PEGASUS study, demonstrating that pegcetacoplan significantly improved hemoglobin levels in patients with paroxysmal nocturnal hemoglobinuria (PNH) compared to eculizumab. This pivotal study was selected for an oral presentation at the 25th European Hematology Association Congress, validating the innovative research and commitment to improve standards of care for PNH patients. Pegcetacoplan has received Fast Track designation from the FDA for treating PNH and is also being evaluated for other conditions.
Apellis Pharmaceuticals (Nasdaq: APLS) announced its participation at the BofA Securities 2020 Health Care Conference on May 14, 2020, at 8:20 a.m. ET. The event will take place virtually, featuring a fireside chat with CEO Cedric Francois. The discussion will be accessible via a live webcast on the company’s Investors and Media page. Following the event, a replay will be available for 90 days. Apellis focuses on developing targeted C3 therapies for diseases caused by excessive complement activation.
Apellis Pharmaceuticals (Nasdaq: APLS) announced equity awards granted to three new employees as an inducement for their acceptance of employment. The awards include options to purchase a total of 112,526 shares, with exercise prices set at $32.02 and $34.11 for options granted on May 1 and May 4, 2020, respectively. The options will vest over four years, contingent on continued employment with the company. This grant was consistent with Nasdaq Listing Rule 5635(c)(4) and was approved in earlier months prior to the awards.
Apellis Pharmaceuticals (Nasdaq: APLS) announced a $300 million private placement of 3.500% convertible senior notes due 2026, with an aggregate purchase price of $328.9 million. The deal closing is expected on May 12, 2020. The notes will be unsecured senior obligations, maturing on September 15, 2026, with an initial conversion rate of 25.3405 shares per $1,000 principal amount. Net proceeds of approximately $323 million will fund clinical development of pegcetacoplan and support commercialization efforts.
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