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, 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.
Apellis Pharmaceuticals reported $15.1 million in net product revenues for EMPAVELI in 2021, marking a successful U.S. launch post-FDA approval for PNH treatment. The company aims to submit a New Drug Application for pegcetacoplan in geographic atrophy by 2Q 2022. Apellis has a promising pipeline with four late-stage and three pre-clinical programs. However, 2021 saw a significant net loss of $746.4 million, up from a $344.9 million loss in 2020, driven by increased R&D expenses totaling $425.9 million.
Apellis Pharmaceuticals (Nasdaq: APLS) will host a conference call and webcast to discuss its fourth quarter and full year 2021 financial results on February 28, 2022, at 4:30 p.m. ET. The call aims to provide insights into the company's performance and future projections. To participate, stakeholders must pre-register for the call. Additionally, a replay of the webcast will be available for 30 days post-event. Apellis is known for developing targeted C3 therapies for various diseases driven by complement cascade activation.
Apellis Pharmaceuticals (APLS) announced the approval of equity inducement awards for a new employee, effective January 3, 2022. The award consists of options to purchase 60,000 shares at an exercise price of $48.77 and 20,000 restricted stock units (RSUs). The options will vest over four years, with 25% vesting on the first anniversary. This action is aligned with Nasdaq Listing Rule 5635(c)(4) and aims to attract talent by providing long-term incentive compensation.
Apellis Pharmaceuticals (Nasdaq: APLS) will present virtually at the 40th Annual J.P. Morgan Healthcare Conference on January 10, 2022, at 8:15 a.m. ET. The presentation will include a live Q&A session and will be accessible via a webcast on the company’s website. A replay will be available for 30 days post-event, along with the presentation slides posted online at 8:00 a.m. ET on the same day. Apellis is focused on developing transformative therapies targeting the complement system for various debilitating diseases.
Apellis Pharmaceuticals announced that the European Commission has approved Aspaveli (pegcetacoplan), the first targeted C3 therapy for paroxysmal nocturnal hemoglobinuria (PNH), aimed at adults who remain anemic after C5 inhibitor treatment. This approval is based on the PEGASUS Phase 3 study showing Aspaveli's effectiveness over eculizumab in improving hemoglobin levels. Aspaveli will enjoy market exclusivity in the EU due to its orphan drug designation, supporting its potential to enhance patient care for PNH.
Apellis Pharmaceuticals (Nasdaq: APLS) and Sobi™ announced positive data for Empaveli™ (pegcetacoplan) in treating paroxysmal nocturnal hemoglobinuria (PNH) at the ASH Annual Meeting. Results from the Phase 3 PRINCE study revealed significant improvements in treatment-naïve patients: 46% achieved hemoglobin normalization without transfusions, with a mean hemoglobin rise from 9.4 g/dL to 12.8 g/dL. The treatment also resulted in rapid reductions in lactate dehydrogenase (LDH) levels. The safety profile was consistent, with lower serious adverse events compared to standard care.
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