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. (Nasdaq: APLS) generates frequent news as a commercial-stage biopharmaceutical company focused on C3 complement science. Its updates often center on the performance and expansion of its approved C3-targeting medicines, SYFOVRE for geographic atrophy (GA) secondary to age-related macular degeneration and EMPAVELI/Aspaveli for complement-mediated rare diseases such as C3 glomerulopathy (C3G), primary IC-MPGN, and paroxysmal nocturnal hemoglobinuria (PNH).
Investors following APLS news can expect regular disclosures on commercial execution, including U.S. net product revenues, patient start forms, market share in GA, and payer coverage trends in C3G and primary IC-MPGN. Apellis also issues news on long-term clinical data, such as five-year GALE extension results for SYFOVRE and one-year VALIANT data for EMPAVELI, which highlight durability of treatment effect and safety profiles.
Another major category of Apellis news involves clinical and regulatory milestones. Releases cover Phase 2 and Phase 3 trial progress, pivotal trial initiations in new nephrology indications like focal segmental glomerulosclerosis and delayed graft function, regulatory approvals, and opinion timelines from agencies such as the U.S. Food and Drug Administration and the European Medicines Agency. The company also announces publication of key data in peer-reviewed journals, including The New England Journal of Medicine.
Corporate and financial communications are a further news stream, including quarterly financial results, cash and cash equivalents updates, royalty and collaboration agreements with partners such as Sobi, and participation in major healthcare and investor conferences. For readers tracking APLS, this news page provides a centralized view of Apellis’ commercial performance, pipeline evolution, regulatory events, and strategic transactions related to its complement-based therapies.
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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