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 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.
Apellis Pharmaceuticals, a leader in complement medicine, will host a conference call and webcast on May 4, 2022, at 4:30 p.m. ET to discuss its first quarter 2022 financial results. The live call can be accessed by pre-registering online, and a replay will be available for 30 days. The company is committed to delivering transformative therapies for rare, retinal, and neurological diseases, highlighted by the launch of the first new class of complement medicine in 15 years with its targeted C3 therapy.
Apellis Pharmaceuticals, a biopharmaceutical leader in complement therapies, will present at the 21st Annual Needham Virtual Healthcare Conference on April 11, 2022, at 3:00 p.m. ET. The conference format will be virtual, and interested parties can access the live webcast on the company’s website under the 'Events and Presentations' section. A replay will be available for 90 days post-event. This presentation highlights Apellis's commitment to innovation in treatments for rare and neurological diseases.
Apellis Pharmaceuticals (Nasdaq: APLS) announced the completion of an underwritten public offering of common stock, raising $402.5 million. This includes the full exercise of underwriters' options to purchase an additional 1,117,021 shares at $47.00 each, totaling 8,563,830 shares sold. Proceeds will fund operations and capital expenses through Q1 2024, alongside existing cash and revenue from EMPAVELI® sales and milestone payments from Sobi. The offering was conducted under an effective shelf registration statement filed with the SEC.
Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) announced the pricing of a public offering of 7,446,809 shares of common stock at $47.00 per share, aiming for total gross proceeds of $350 million, before deductions. The offering, expected to close on March 28, 2022, includes a 30-day option for underwriters to purchase an additional 1,117,021 shares. The shares will be sold under a shelf registration statement filed with the SEC. Leading financial firms J.P. Morgan, Goldman Sachs, and Evercore are managing the offering.
Apellis Pharmaceuticals (Nasdaq:APLS) has announced a public offering of $300 million in common stock, with an additional 15% option for underwriters. The offering is underwritten by J.P. Morgan, Goldman Sachs, and Evercore. This initiative is part of their ongoing strategy to leverage capital for future growth. The offering aligns with a previously filed SEC registration statement. It emphasizes Apellis' commitment to advancing therapies in complement medicine, particularly for rare diseases.
Apellis Pharmaceuticals (APLS) released positive data from the Phase 3 DERBY and OAKS studies, showcasing that intravitreal pegcetacoplan effectively reduces geographic atrophy (GA) lesion growth after 18 months. Both monthly and every-other-month treatments demonstrated significant efficacy with p-values below 0.05. The favorable safety profile was maintained, with low rates of infections. These results will support a New Drug Application (NDA) submission to the FDA planned for Q2 2022, with a conference call scheduled for today to discuss findings.
Apellis Pharmaceuticals (Nasdaq: APLS) announced participation in two upcoming investor conferences in March 2022. The Cowen 42nd Annual Health Care Conference will feature a fireside chat on March 9, 2022, at 12:50 p.m. ET, while the Oppenheimer 32nd Annual Healthcare Conference will take place on March 16, 2022, at 12:40 p.m. ET. Both events will be accessible via live webcast on the company’s website, with replays available for 90 days post-event. Apellis focuses on innovative therapies for diseases linked to the complement system.
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