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 it received formal FDA feedback supporting its plans to submit a New Drug Application (NDA) for intravitreal pegcetacoplan aimed at treating geographic atrophy (GA) due to age-related macular degeneration. The NDA will utilize data from the Phase 3 DERBY and OAKS studies, alongside the Phase 2 FILLY study, all deemed adequate by the FDA. Apellis aims to submit the NDA in H1 2022 without needing additional trials. Over 1,500 patients participated in these studies, highlighting the company's commitment to addressing GA, a leading cause of blindness.
Apellis Pharmaceuticals (APLS) announced the presentation of Phase 3 DERBY and OAKS trial data for pegcetacoplan at the AAO Annual Meeting from Nov 12-15, 2021. Pegcetacoplan, an investigational C3 therapy, demonstrated clinically meaningful reductions in geographic atrophy (GA) lesion growth in patients with age-related macular degeneration. While achieving the primary endpoint in OAKS, it narrowly missed in DERBY. The company plans to file a New Drug Application with the FDA in the first half of 2022, marking a significant step toward addressing a condition with no approved treatments worldwide.
Apellis Pharmaceuticals reported $5.3 million in net product revenues from EMPAVELI in Q3 2021, contributing to total revenues of $5.7 million. The company received a positive opinion from the CHMP for pegcetacoplan in PNH and anticipates a decision by the European Commission by year-end. Apellis is on track to submit a New Drug Application for pegcetacoplan for geographic atrophy by mid-2022, with promising trial results indicating significant GA lesion growth reduction. However, net loss increased to $195.6 million, up from $135.7 million a year prior.
Apellis Pharmaceuticals announced the acceptance of five abstracts for the upcoming American Society of Hematology (ASH) Annual Meeting, including the positive Phase 3 PRINCE study of EMPAVELI in treatment-naïve patients with paroxysmal nocturnal hemoglobinuria (PNH). Results indicated EMPAVELI’s superiority in hemoglobin stabilization and LDH reduction at Week 26 compared to standard care. The study assessed 53 adults, showcasing EMPAVELI's potential to enhance treatment for all PNH patients, regardless of prior hemoglobin levels. The oral presentation is scheduled for December 13, 2021.
Apellis Pharmaceuticals (Nasdaq: APLS) is set to participate in two major investor conferences in November 2021. The company will hold a fireside chat at the Credit Suisse 30th Annual Healthcare Conference on November 10 at 4:20 p.m. ET and a formal presentation at the Stifel Healthcare Conference on November 15 at 4:00 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 is a leader in targeted C3 therapies aimed at treating various serious diseases.
Apellis Pharmaceuticals (APLS) has announced a conference call and webcast set for November 8, 2021, at 4:30 p.m. ET to discuss its third quarter 2021 financial results. Interested participants can register for the call via a provided link, with conference ID 1931859. The event will also be accessible through a live audio webcast on the company’s website, with a replay available for 90 days afterward. Apellis is known for its commitment to developing targeted C3 therapies aimed at debilitating diseases across multiple medical fields, including hematology and ophthalmology.
Apellis Pharmaceuticals (APLS) and Sobi have announced a positive opinion from the European Medicines Agency's CHMP for Aspaveli® (pegcetacoplan) to treat adults with paroxysmal nocturnal hemoglobinuria (PNH) who remain anemic after at least three months on a C5 inhibitor. This recommendation is now forwarded to the European Commission for review. Aspaveli aims to provide a new treatment option for the approximately 72% of patients still anemic after C5 therapy. This follows recent U.S. approval for the same indication, which could significantly impact treatment paradigms for PNH in Europe.
Apellis Pharmaceuticals (APLS) announced the grant of equity awards to three new employees, effective October 1, 2021. The awards include options for 32,000 shares and 1,000 restricted stock units (RSUs), with an exercise price of $33.59, matching the stock's closing price on the grant date. The options will vest over four years, while the RSUs will vest 25% annually. This action, aligned with Nasdaq Listing Rule 5635(c)(4), is a strategic move to attract talent critical for the company's growth in targeted C3 therapies.
Apellis Pharmaceuticals (APLS) presented Phase 3 study results for pegcetacoplan, a targeted C3 therapy, at the Retina Society Annual Scientific Meeting. The OAKS trial showed significant reduction in geographic atrophy (GA) lesion growth with monthly (p=0.0003) and every-other-month (p=0.0052) treatments. The DERBY trial showed a reduction in lesion growth but narrowly missed the primary endpoint. Pegcetacoplan could become the first treatment for GA, which affects over five million globally. An NDA is planned for submission in H1 2022.
Apellis Pharmaceuticals (Nasdaq: APLS) announced its participation in the 2021 Cantor Virtual Global Healthcare Conference, scheduled for September 27, 2021, at 8:40 a.m. ET. The conference will be conducted virtually and accessible via a live webcast on the company’s website. A replay will be available for 90 days post-event. Apellis, a leader in targeted C3 therapies, focuses on transformative solutions for diseases caused by complement cascade activation.
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