WALTHAM, Mass., Jan. 27, 2025 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) announced today that the Therapeutic Goods Administration (TGA) has approved SYFOVRE® (pegcetacoplan) for the every-other-month treatment of adult patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD) with an intact fovea and when central vision is threatened by GA lesion growth. SYFOVRE is the first and only approved treatment for GA in Australia. "The approval of SYFOVRE marks ...

Bronstein, Gewirtz & Grossman, LLC Is Investigating Apellis Pharmaceuticals, Inc. (APLS) And Encourages Shareholders to Connect ...

Bronstein, Gewirtz & Grossman, LLC Initiates an Investigation into Allegations Against Apellis Pharmaceuticals, Inc. (APLS) And Encourages Shareholders to Reach Out ...

Core Viewpoint - Apellis Pharmaceuticals, Inc. (APLS) is currently under investigation by Bronstein, Gewirtz & Grossman, LLC, which is encouraging investors to reach out for more information regarding the investigation [1] Group 1 - The investigation pertains to potential securities violations by Apellis Pharmaceuticals [1] - Investors are being urged to contact the firm to learn more about the implications of the investigation [1] - The investigation may impact investor confidence and the company's stock performance [1]

SYFOVRE Performance and Market Position - SYFOVRE achieved $611 million in U.S. net product revenues for full-year 2024, with $167 million in Q4 2024[5][19] - Over 510,000 SYFOVRE injections administered through December 2024, including clinical trials[3][6] - Distributed approximately 94,000 SYFOVRE doses (commercial and sample vials) to physician practices in Q4 2024[6] - SYFOVRE demonstrated more than 120% year-over-year net sales growth, solidifying its position as the market-leading treatment for GA[3] EMPAVELI Revenue and Development - EMPAVELI generated $98 million in U.S. net product revenues for full-year 2024, with $23 million in Q4 2024[5][19] - Apellis plans to submit EMPAVELI sNDA for C3G and primary IC-MPGN in early 2025, with a U.S. launch anticipated in 2H 2025 if approved[5][15] - EMPAVELI may cause embryo-fetal harm, requiring pregnancy testing and effective contraception for females of reproductive potential[34] Financial Position and Strategic Focus - Apellis ended 2024 with approximately $410 million in cash and cash equivalents, up from $351.2 million in 2023[18] - Apellis plans to reduce ex-U.S. footprint by approximately 40 employees as part of prioritizing U.S. commercial efforts[6] - The company's cash resources are expected to fund operations for a certain period, subject to adjustments and financial closing procedures[37] Clinical Trials and Future Plans - Phase 3 studies of pegcetacoplan in two additional nephrology indications planned for initiation in 2H 2025[5][15] - Phase 1b/2 multi-dose study of APL-3007 (siRNA) + SYFOVRE expected to initiate in Q2 2025[6] - The company plans to initiate Phase 3 studies of pegcetacoplan in FSGS and DGF[37] - Apellis expects to achieve profitability, with timing dependent on various factors including clinical trial results and regulatory approvals[37] Product Portfolio and Innovation - Apellis Pharmaceuticals has two approved medicines targeting C3, including the first-ever therapy for geographic atrophy[36]

Reports $709 million in preliminary1 full-year 2024 U.S. net product revenues $611 million in SYFOVRE® U.S. net product revenues, including $167 million in 4Q 2024$98 million in EMPAVELI® U.S. net product revenues, including $23 million in 4Q 2024 Expects submission of EMPAVELI sNDA for C3G and primary IC-MPGN in early 2025; U.S. launch anticipated in 2H 2025, if approvedPlans initiation of Phase 3 studies of pegcetacoplan in two additional nephrology indications in 2H 2025Adam Townsend, chief operating of ...

WALTHAM, Mass., Jan. 10, 2025 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) today announced that Keli Walbert will join the Apellis Board of Directors, effective immediately. Ms. Walbert brings more than two decades of biopharmaceutical commercial leadership experience to the Board. “We are delighted to welcome Keli to the Apellis Board of Directors,” said Cedric Francois, M.D., Ph.D., chief executive officer and co-founder, Apellis. “Keli has a proven track record of successfully bringin ...

WALTHAM, Mass., Jan. 06, 2025 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) today announced that the company will present at the 43rd Annual J.P. Morgan Healthcare Conference on Monday, January 13, 2025, at 9:45 a.m. PT. The live conference webcast will be posted on the “Events and Presentations” page of the “Investors and Media” section of the company’s website. A replay of the webcast will be available for approximately 90 days following the event. About ApellisApellis Pharmaceuticals, ...

Legal Investigation - Bragar Eagel & Squire, P C is investigating potential claims against Apellis Pharmaceuticals Inc on behalf of long-term stockholders following a class action complaint filed on August 2 2023 with a Class Period from January 28 2021 to July 28 2023 [2] - The investigation concerns whether the board of directors of Apellis breached their fiduciary duties to the company [2] Allegations - The Complaint alleges that Defendants made materially false and/or misleading statements and failed to disclose material adverse facts about Apellis Pharmaceuticals' business and operations during the Class Period [3] - Specifically, Defendants allegedly misrepresented and/or failed to disclose that the design of SYFOVRE's clinical trials was insufficient to identify incidents of retinal vasculitis in patients receiving SYFOVRE injections [3] - As a result, the commercial adoption of SYFOVRE was subject to significant unknown risk factors [3] - Therefore, Defendants' statements about the company's business operations and prospects lacked a reasonable basis [3]

Apellis Pharmaceuticals, Inc. (APLS) incurred third-quarter 2024 loss of 46 cents per share, wider than the Zacks Consensus Estimate of a loss of 32 cents. The company had incurred a loss of $1.17 per share in the year-ago quarter.Total revenues in the third quarter amounted to $196.8 million and missed the Zacks Consensus Estimate of $199 million. In the year-ago quarter, the company had reported revenues of $110.4 million.The top line jumped 78.3% year over year, owing to higher sales of Syfovre (pegcetac ...