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) and Sobi have commenced the Phase 3 VALIANT study for pegcetacoplan, targeting primary immune-complex membranoproliferative glomerulonephritis (IC-MPGN) and C3 glomerulopathy (C3G). This study addresses a significant unmet need, as these rare conditions currently lack approved treatments. The trial involves approximately 90 patients aged 12 and older, with a primary endpoint of achieving at least a 50% reduction in urine protein-to-creatinine ratio after 26 weeks. The results of this study could have substantial implications for patient care and market potential.
Apellis Pharmaceuticals (Nasdaq: APLS) announced the approval of equity inducement awards for thirteen new employees, effective June 1, 2022. These awards included options to purchase 55,900 shares and 72,711 restricted stock units (RSUs). The options were granted at an exercise price of $41.35, matching the stock's closing price on the grant date. Vesting will occur over four years for options and annually for RSUs, contingent on continued employment. This initiative aligns with Nasdaq Listing Rules, supporting talent acquisition in the competitive biopharmaceutical sector.
Apellis Pharmaceuticals (Nasdaq: APLS) announced its participation in two major investor conferences in June 2022. The Jefferies Healthcare Conference features a fireside chat on June 9, 2022, at 4:30 p.m. ET, while the Goldman Sachs 43rd Annual Global Healthcare Conference will take place on June 15, 2022, at 9:20 a.m. PT. Both events will be available via live webcast and can be accessed from the company's website. Following the events, webcasts will be replayable for 90 days.
Apellis Pharmaceuticals (APLS) announced the submission of a New Drug Application (NDA) to the FDA for pegcetacoplan, targeting geographic atrophy (GA) secondary to age-related macular degeneration (AMD). GA affects over 5 million people worldwide, with no current approved treatments. Pegcetacoplan has shown promise in reducing GA lesion growth in Phase 3 studies, DERBY and OAKS, as well as the Phase 2 FILLY study. The FDA is expected to respond to the NDA by August 2022.
Apellis Pharmaceuticals (Nasdaq: APLS) announced that it will present seven abstracts at the European Hematology Association (EHA) Congress from June 9-12 in Vienna, focusing on EMPAVELI® (pegcetacoplan) for treating paroxysmal nocturnal hemoglobinuria (PNH).
The highlights include an oral presentation on quality of life improvements and several posters showcasing efficacy and safety data.
EMPAVELI is gaining traction as a potential new standard of care for PNH, with ongoing investigations for additional indications.
Apellis Pharmaceuticals (APLS) announced the approval of equity inducement awards to four new employees on May 2, 2022, under its 2022 Inducement Stock Incentive Plan. The awards consist of options to purchase 19,031 shares and 23,332 restricted stock units (RSUs). The exercise price for options is set at $44.96, reflecting the stock's closing price on the grant date. Vesting for options will occur over four years, while RSUs will vest over four years as well, contingent on ongoing employment.
Apellis Pharmaceuticals (Nasdaq: APLS) announced its participation at the Bank of America Securities 2022 Healthcare Conference on May 11, 2022, at 8:40 a.m. PT. The event will feature a live webcast accessible through the company’s website, and a replay will be available for 30 days afterward.
As a leader in complement therapies, Apellis focuses on developing transformative treatments for diseases related to complement cascade activation across various fields, including hematology, ophthalmology, nephrology, and neurology.
Apellis Pharmaceuticals reported $12.1 million in U.S. net product revenues for EMPAVELI® (pegcetacoplan) in Q1 2022, with total revenues reaching $14.4 million. The company is on track to submit a New Drug Application (NDA) for pegcetacoplan in geographic atrophy by Q2 2022 and completed enrollment in a Phase 2 study for amyotrophic lateral sclerosis (ALS). Cash and investments totaled $965.3 million as of March 31, 2022, ensuring a runway into Q1 2024. Despite a net loss of $138.9 million, the firm is optimistic about its growth trajectory.
Apellis Pharmaceuticals (Nasdaq: APLS) has appointed Peter Hillmen, a prominent hematologist, as the head of hematology engagement, effective May 23, 2022. Hillmen brings decades of expertise in paroxysmal nocturnal hemoglobinuria (PNH), having developed treatments including EMPAVELI (pegcetacoplan). His role will focus on expanding collaborations with U.S. hematology leaders and enhancing Apellis' initiatives. EMPAVELI is positioned as a potential new standard of care for PNH, demonstrating superior effectiveness compared to existing therapies.
Apellis Pharmaceuticals (APLS) reported promising long-term results from the Phase 3 DERBY and OAKS studies for pegcetacoplan, a targeted C3 therapy, showing significant reductions in geographic atrophy (GA) lesion growth after 18 months.
Monthly and every-other-month treatments led to reductions of up to 33% for extrafoveal lesions and 19% for foveal lesions (p<0.0001). This positions pegcetacoplan as a potential first treatment for GA, a leading cause of blindness affecting over 5 million globally. Apellis plans to submit a New Drug Application to the FDA in Q2 2022.
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