S&P 500 may face selling pressure as systematic funds reach full exposure
BRIDGEWATER, N.J. - Amneal Pharmaceuticals, Inc. (NASDAQ:AMRX), in collaboration with biotechnology firm mAbxience, has announced the U.S. Food and Drug Administration’s (FDA) acceptance of their Biologics Licensing Application (BLA) for two biosimilars of denosumab, a drug used for bone-related conditions. The FDA has set a target action date for the fourth quarter of 2025.
Denosumab is used to treat bone metastasis from cancer and to prevent bone fractures in conditions like osteoporosis. The biosimilars, if approved, would reference the brand-name drugs Prolia® and XGEVA®. Amneal, which currently markets three biosimilars in the U.S., could potentially launch these two additional biosimilars. With three more biosimilars under development, the company aims to have a portfolio of six biosimilars across eight product presentations by 2027.
mAbxience, which is responsible for the development and manufacturing of the biosimilars, is a Fresenius Kabi majority-owned group with partial ownership from Insud Pharma. The partnership between Amneal and mAbxience has previously resulted in the launch of ALYMSYS®, a bevacizumab biosimilar, in 2022.
The proposed biosimilars could offer more affordable alternatives to the reference drugs, which, according to IQVIA®, generated U.S. annual sales of approximately $5.0 billion for the 12 months ended December 2024. Analysts tracked by InvestingPro are optimistic about Amneal’s prospects, with price targets ranging from $11 to $12, and expectations of profitability this year. Get access to detailed financial analysis and 8 additional ProTips about AMRX through InvestingPro’s comprehensive research reports.
The acceptance of the BLA by the FDA marks a step forward for Amneal as it seeks to expand its presence in the U.S. biosimilars market. This move aligns with the company’s strategy to increase patient access to biologic therapies, supported by its strong current ratio of 1.41 and improving financial metrics.
The information in this article is based on a press release statement from Amneal Pharmaceuticals, Inc.
In other recent news, Amneal Pharmaceuticals reported its Q4 2024 earnings, revealing a slight miss on earnings per share (EPS) expectations, with an EPS of $0.12 compared to the anticipated $0.15. However, the company exceeded revenue forecasts, bringing in $731 million against the expected $703.74 million. Amneal Pharmaceuticals has also launched a new Parkinson’s drug, Krexant, which has shown promising sales targets and exceeded expectations with 30% formulary coverage. The company is aiming for significant growth in the biosimilars market and has set a revenue guidance range of $3.0 to $3.1 billion for 2025, implying a growth rate of 7-11%. Additionally, Amneal has been reducing its net leverage, now at 3.9x, down from 4.8x the previous year, and has received credit upgrades from S&P and Moody’s. In terms of analyst activity, Amneal Pharmaceuticals received credit upgrades from both S&P and Moody’s, reflecting confidence in its financial profile. The company continues to focus on organic growth and strategic investments, with plans to expand its biosimilars pipeline and launch new products.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.