Welcome to our dedicated page for Apellis Pharmace news (Ticker: APLS), a resource for investors and traders seeking the latest updates and insights on Apellis Pharmace stock.
Apellis Pharmaceuticals, Inc. (APLS) is a leader in developing transformative therapies targeting the complement system, with approved treatments for geographic atrophy and rare blood disorders. This page provides investors and researchers with essential updates on the company’s progress in retinal, hematologic, and renal disease innovation.
Access timely announcements including FDA decisions, clinical trial results, and strategic partnerships that demonstrate Apellis’ commitment to advancing complement immunotherapy. Our curated news collection covers critical developments such as SYFOVRE’s commercial adoption, EMPAVELI’s clinical applications, and research collaborations expanding therapeutic pipelines.
Key updates include regulatory milestones in ophthalmology, hematology treatment expansions, and nephrology research advancements. Bookmark this page to stay informed about Apellis’ pioneering work in C3-targeted therapies and its impact on addressing diseases with limited treatment options.
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.
Apellis Pharmaceuticals (Nasdaq: APLS) has granted equity awards to 8 new employees as equity inducement awards under the 2022 Inducement Stock Incentive Plan. The awards were approved on October 3, 2022, in compliance with Nasdaq Listing Rule 5635(c)(4). Each employee received options to purchase 38,840 restricted stock units (RSUs), which will vest annually over four years, contingent on continued employment. This move is part of Apellis' strategy to attract talent and enhance its strong position in the biopharmaceutical industry, particularly in complement medicine.
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