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The FDA accepts Apellis' sNDA seeking label expansion of Empaveli to treat two rare kidney diseases for review under the Priority Review pathway.
The U.S. Food and Drug Administration (FDA) on Tuesday accepted and granted Priority Review designation to Apellis Pharmaceuticals, Inc.'s APLS supplemental New Drug Application (sNDA) for Empaveli (pegcetacoplan) for C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN).
PDUFA target action date is July 28, 2025 WALTHAM, Mass., April 01, 2025 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review designation of the supplemental New Drug Application (sNDA) for EMPAVELI® (pegcetacoplan) for C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN), which are severe and rare kidney diseases.
Commerical stage Apellis Pharmaceuticals, Inc. recently reported Q4 results that beat expectations. The company posted impressive revenue growth and cost reduction in FY2024. It is a bit of a complicated tale around this mid-cap, but the company looks set to move to profitability with the funding it has on hand.
Last week, Apellis Pharmaceuticals Inc APLS reported a fourth-quarter earnings loss of 29 cents per share, beating the consensus loss of 37 cents. Sales increased 45.2% to $212.5 million, beating the consensus of $198.35 million.
APLS reports better-than-expected fourth-quarter 2024 results, wherein both earnings and revenues beat estimates, driven by strong sales of Syfovre.
Apellis Pharmaceuticals, Inc. (NASDAQ:APLS ) Q4 2024 Earnings Conference Call February 28, 2025 8:30 AM ET Company Participants Cedric Francois - Co-Founder and CEO Caroline Baumal - Chief Medical Officer David Acheson - EVP, Commercial Tim Sullivan - CFO Meredith Kaya - SVP, IR and Strategic Finance Conference Call Participants Jon Miller - Evercore ISI Tazeen Ahmad - Bank of America Securities Malcolm Kuno - J.P. Morgan Salveen Richter - Goldman Sachs Yigal Nochomovitz - Citigroup Colleen Cusi - Robert W.
Although the revenue and EPS for Apellis Pharmaceuticals (APLS) give a sense of how its business performed in the quarter ended December 2024, it might be worth considering how some key metrics compare with Wall Street estimates and the year-ago numbers.
Apellis Pharmaceuticals, Inc. (APLS) came out with a quarterly loss of $0.29 per share versus the Zacks Consensus Estimate of a loss of $0.39. This compares to loss of $0.73 per share a year ago.
WALTHAM, Mass., Feb. 28, 2025 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS), today announced its fourth quarter and full year 2024 financial results and business highlights.