BRIDGEWATER, N.J. - Amneal Pharmaceuticals, Inc. (NASDAQ:AMRX) announced two significant regulatory developments affecting its product lineup. The company has resubmitted a New Drug Application (NDA) for its dihydroergotamine (DHE) autoinjector to the U.S. Food and Drug Administration (FDA) and has received FDA approval for exenatide, a generic injectable glucagon-like peptide-1 (GLP-1) agonist.
The DHE autoinjector, described as the first of its kind, is intended for the acute treatment of migraine with or without aura and cluster headaches in adults. The device is designed for ease of use, allowing patients to self-administer a single dose without the need for refrigeration, assembly, or priming. Following a complete response letter from the FDA which cited issues at a third-party facility, Amneal transferred production in-house. The FDA's review of the resubmitted NDA is anticipated to conclude in the second quarter of 2025.
Joe Renda, Senior Vice President, Chief Commercial Officer - Specialty at Amneal, expressed optimism about providing a new solution for patients suffering from severe migraines and cluster headaches. DHE is a medication traditionally administered in clinical settings but is also available in other at-home use formulations.
In a separate development, Amneal received FDA approval for exenatide, which is used alongside diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. This marks one of the first generic GLP-1 injectables approved in the U.S. Andy Boyer, Executive Vice President, Chief Commercial Officer - Generics, highlighted the approval as a reflection of the company's innovation in complex pharmaceutical development.
While exenatide has been associated with certain side effects including changes in kidney function, low blood sugar, and inflammation of the pancreas, it is a significant addition to Amneal's portfolio, which includes over 280 generic and specialty pharmaceuticals.
The information reported is based on a press release statement from Amneal Pharmaceuticals, Inc.
In other recent news, Amneal Pharmaceuticals reported robust third-quarter financial results, with an adjusted diluted earnings per share of $0.16 on revenues of $702 million, surpassing the Street's expectations. This was accompanied by a 13% increase in revenue, indicating strong performance across its generics and specialty product lines. Piper Sandler, a financial services firm, has subsequently upgraded its stock price target for Amneal Pharmaceuticals from $9.00 to $11.00, maintaining its Overweight rating on the stock.
Amneal's strategic moves such as the launch of CREXONT for Parkinson's disease, a partnership with Metsera for obesity treatment, and plans to expand manufacturing capabilities with two new facilities in India have contributed to this surge in revenue. The company's revenue from affordable medicines also grew by 12%, contributing an additional $35 million due to new product launches.
Amneal has confirmed its revenue and adjusted EBITDA guidance for the full year of 2024, projecting ranges of $2.7 billion to $2.8 billion and $610 million to $630 million, respectively. The company anticipates healthcare distribution revenues to exceed $700 million by 2025, with international expansion adding an additional $50-100 million by 2027. These recent developments suggest clear prospects for sustained growth in the long term, according to Piper Sandler.
InvestingPro Insights
Amneal Pharmaceuticals' recent regulatory developments align with its growth trajectory, as reflected in the company's financial metrics and market performance. According to InvestingPro data, Amneal's revenue grew by 12.32% over the last twelve months, reaching $2.68 billion. This growth is particularly relevant given the company's recent FDA approval for exenatide, which could potentially contribute to future revenue streams.
The company's stock has shown strong performance, with a remarkable 88.14% price total return over the past year. This upward trend could be attributed to investor optimism surrounding Amneal's product pipeline and regulatory progress, such as the resubmission of the DHE autoinjector NDA and the exenatide approval.
InvestingPro Tips highlight that Amneal's net income is expected to grow this year, which aligns with the potential market opportunities presented by its new and pending product approvals. Additionally, the company's valuation implies a strong free cash flow yield, suggesting that Amneal may be well-positioned to fund its ongoing research and development efforts.
It's worth noting that while Amneal was not profitable over the last twelve months, analysts predict the company will be profitable this year. This projection could be influenced by the anticipated launch of new products like exenatide and potentially the DHE autoinjector in the future.
For investors seeking more comprehensive analysis, InvestingPro offers 11 additional tips for Amneal Pharmaceuticals, providing a deeper understanding of the company's financial health and market position.
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