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) will present at the 41st Annual J.P. Morgan Healthcare Conference on January 9, 2023, at 9:00 a.m. PT / 12:00 p.m. ET. The event will be available via a live webcast on the company’s website, with a replay accessible for 90 days post-event. Apellis is recognized for pioneering complement medicine, having launched the first approved targeted C3 therapy, and is focused on developing transformative treatments for rare retinal and neurological diseases.
Apellis Pharmaceuticals (Nasdaq: APLS) has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency for pegcetacoplan, targeting geographic atrophy (GA) due to age-related macular degeneration (AMD). This application is based on Phase 3 DERBY and OAKS trials, showing significant reductions in GA lesion growth over 24 months. If approved, pegcetacoplan would be the first treatment for GA in Europe. The FDA review is pending with a PDUFA date of February 26, 2023, highlighting the urgency for treatment in a disease that severely impacts more than five million globally.
Apellis Pharmaceuticals (Nasdaq: APLS) recently announced the approval of equity inducement awards for two new employees, effective December 1, 2022. The awards include options to purchase 8,790 restricted stock units (RSUs), which will vest annually at 25% over four years, contingent on the employees' continued employment. This move aligns with Nasdaq Listing Rule 5635(c)(4) and is aimed at attracting talent by offering competitive compensation through equity opportunities. Apellis remains committed to advancing innovative therapies in complement medicine.
Apellis Pharmaceuticals (Nasdaq: APLS) has announced its participation in two upcoming investor conferences. The first is the 5th Annual Evercore ISI HealthCONx Conference, featuring a fireside chat scheduled for November 29, 2022, at 8:25 a.m. ET. The second is the Bank of America 2022 Virtual Biotech SMID Cap Conference, set for December 7, 2022, at 9:40 a.m. ET. Both events will be accessible via live webcast on the company's website, with replays available for 90 days.
Apellis Pharmaceuticals (Nasdaq: APLS) announced that the FDA accepted its unsolicited amendment to the New Drug Application (NDA) for intravitreal pegcetacoplan, aimed at treating geographic atrophy (GA) due to age-related macular degeneration (AMD). The new PDUFA goal date is set for February 26, 2023. The FDA also stated no advisory committee meeting will occur. The 24-month clinical data from Phase 3 studies DERBY and OAKS was included, suggesting a strong product profile with efficacy and safety. Apellis plans to submit an EU marketing application by the end of 2022.
Apellis Pharmaceuticals (APLS) reported Q3 2022 net product revenues of $17.7 million from EMPAVELI, contributing to total revenues of $22.1 million. The company plans to submit 24-month Phase 3 efficacy data for intravitreal pegcetacoplan for geographic atrophy (GA) to the FDA, with a PDUFA target action date set for February 2023. Cash and investments reached $708.6 million, providing a strong cash runway into Q1 2024. R&D expenses increased to $95.2 million. Despite a net loss of $191.3 million, Apellis continues to advance its product pipeline.
On November 4, 2022, Apellis Pharmaceuticals (Nasdaq: APLS) announced the approval of equity awards for 7 new employees as part of their 2022 Inducement Stock Incentive Plan. A total of 20,375 restricted stock units (RSUs) were granted, with 25% vesting after one year and the remainder vesting annually, dependent on continued employment. This initiative aligns with Nasdaq Listing Rule 5635(c)(4) and supports the company's growth strategy in the biopharmaceutical sector.
Apellis Pharmaceuticals (APLS) has announced plans to submit 24-month efficacy data from the Phase 3 DERBY and OAKS studies as part of its New Drug Application (NDA) for intravitreal pegcetacoplan, targeting geographic atrophy (GA) related to age-related macular degeneration (AMD). This submission will be a Major Amendment, extending the review period by three months with a new PDUFA target action date of February 2023. The company anticipates that these long-term data will strengthen the product profile at launch with minimal impact on the launch timeline originally scheduled for January.
Apellis Pharmaceuticals announced positive results from its long-term extension study of EMPAVELI (pegcetacoplan) for treating adults with paroxysmal nocturnal hemoglobinuria (PNH). The study, to be presented at the ASH Annual Meeting on Dec. 10, shows sustained improvements over two years, with mean hemoglobin levels at 11.6 g/dl, 83% of patients transfusion-free, and 73% achieving normalized lactate dehydrogenase levels. The therapy demonstrated efficacy in both treatment-naïve and previously treated patients, with no new safety concerns reported.
Apellis Pharmaceuticals (APLS) has announced a conference call scheduled for November 7, 2022, at 4:30 p.m. ET to discuss its third quarter 2022 financial results. The live call will be accessible via phone and through a webcast available on the company's website. The firm is recognized for pioneering the first new class of complement medicine in 15 years, aiming to develop transformative therapies for rare, retinal, and neurological diseases. Further information on the event and the company can be found on their official website.
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