Latest news with #Empaveli
Medscape
30-07-2025
- Health
- Medscape
Empaveli Approved for C3G and Primary IC-MPGN
The FDA has approved pegcetacoplan (Empaveli, Apellis Pharmaceuticals, Inc.) for the treatment of C3 glomerulopathy (C3G) or primary immune complex membranoproliferative glomerulonephritis (IC-MPGN) in patients aged 12 years and older. C3G and primary IC-MPGN are rare kidney diseases affecting approximately 5000 people in the US, particularly adolescents or young adults. They often lead to kidney failure requiring dialysis or kidney transplant. In the recently released Phase 3 VALIAN Trial 52-week results, patients receiving pegcetacoplan achieved and maintained a significant reduction in proteinuria over baseline, with a mean urine protein-to-creatinine ratio change at week 26 of -68.1% and at week 52 of -67.2%. In addition, the pegcetacoplan group showed a reduction in estimated glomerular filtration rate levels of -1.2 mL/min/1.73 m2 at week 26 and -3.7 mL/min/1.73 m2 at week 52. The most common adverse reactions were infusion site reactions, pyrexia, nasopharyngitis, influenza, cough, and nausea, according to a company press release. The product will carry a black box warning stating, 'Empaveli, a complement inhibitor, increases the risk of serious infections, especially those caused by encapsulated bacteria, such as Streptococcus pneumoniae, Neisseria meningitidis, and Haemophilus influenzae type B. 'Because of the risk of serious infections caused by encapsulated bacteria, Empaveli is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the EMPAVELI REMS.' Kathleen Dallessio is the Senior Editor for Diabetes & Endocrinology and Nephrology at Medscape Medical News.
Yahoo
22-03-2025
- Business
- Yahoo
Morgan Stanley says Fabhalta's label leaves opportunity for Apellis' Empaveli
Morgan Stanley analyst Judah Frommer notes that Novartis (NVS) has received FDA approval for Fabhalta for C3G. The label comes with a few important restrictions/caveats that leave room for Apellis's (APLS) Empaveli to differentiate itself. The firm highlights that Fabhalta is indicated for adults with C3G, and is indicated to reduce proteinuria. Moreover, the label explicitly states that outcomes have not been established in post-transplant patients. Morgan Stanley says that overall, the restricted label language for Fabhalta and the strength of the VALIANT data set do little to alter its assumption that Empaveli can commercialize as a leader in C3G/ICMPGN. Recall, the sNDA for Empaveli in C3G/IC-MPGN has been submitted. If approved, Apellis expects a commercial launch in the second half of 2025. The firm sees significant potential for Empaveli in these indications, modeling peak U.S. adjusted revenue of $550M, which contributes $12 to its $30 price target on Equal Weight-rated Apellis. Easily identify stocks' risks and opportunities. Discover stocks' market position with detailed competitor analyses. Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>> See today's best-performing stocks on TipRanks >> Read More on APLS: Questions or Comments about the article? Write to editor@ Apellis Pharmaceuticals: Favorable Market Positioning and Strong Clinical Results Justify Buy Rating Buy Rating for Apellis Pharmaceuticals Driven by Empaveli's Market Potential and Efficacy in C3G Treatment JPMorgan healthcare analysts hold an analyst/industry conference call Apellis price target raised to $54 from $50 at JPMorgan Apellis price target lowered to $29 from $30 at Wedbush Sign in to access your portfolio
Yahoo
05-03-2025
- Business
- Yahoo
Apellis Lead Drug Pegcetacoplan Represents Differentiated Asset: JP Morgan Analyst
Last week, Apellis Pharmaceuticals Inc (NASDAQ: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. JP Morgan maintains the Overweight rating with a price forecast of $54. Analyst Anupam Rama says Apellis' lead asset, pegcetacoplan (Syfovre/Empaveli), represents a differentiated asset in the complement space, with opportunities across ophthalmology, hematology, neurology, and nephrology indications. Also Read: The company generated Syfovre sales of $167.8 million and $611.9 million for the fourth quarter and full year 2024, respectively. Delivered approximately 94,000 Syfovre doses to physician practices in the fourth quarter, including approximately 89,000 commercial vials and 4,600 samples. More than 510,000 Syfovre injections, including clinical trials, are estimated to have been administered since launch through December 2024. JP Morgan views Syfovre as an over $1.5 billion peak potential drug, even with conservative assumptions. 'Overall, physicians continue to use the product, driving growth, and we anticipate a fundamental and sentiment shift driving upside in APLS shares,' the analyst writes. Analyst Rama also expects that the Empaveli C3 glomerulopathy and primary immune complex glomerulonephritis (C3G/IC-MPGN) opportunity will be a driver for Apellis stock. The company has submitted a supplemental marketing application for approval of Empaveli based on Phase 3 VALIANT results at six months; if approved, a U.S. launch is expected in 2H 2025. Price Action: APLS stock is up 3.27% at $25.87 at the last check Wednesday. Read Next:Date Firm Action From To Mar 2022 Goldman Sachs Maintains Buy Mar 2022 Raymond James Maintains Strong Buy Jan 2022 Raymond James Maintains Strong Buy View More Analyst Ratings for APLS View the Latest Analyst Ratings Up Next: Transform your trading with Benzinga Edge's one-of-a-kind market trade ideas and tools. Click now to access unique insights that can set you ahead in today's competitive market. Get the latest stock analysis from Benzinga? APELLIS PHARMACEUTICALS (APLS): Free Stock Analysis Report This article Apellis Lead Drug Pegcetacoplan Represents Differentiated Asset: JP Morgan Analyst originally appeared on © 2025 Benzinga does not provide investment advice. All rights reserved. Sign in to access your portfolio
