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BRIDGEWATER, N.J. - Amneal Pharmaceuticals, Inc. (NASDAQ:AMRX), a pharmaceutical company with a market capitalization of $2.64 billion and rated "GREAT" for financial health according to InvestingPro, has received approval from the U.S. Food and Drug Administration (FDA) for three new therapies aimed at treating dementia, oncology, and gastrointestinal conditions. The company announced today that it has launched memantine/donepezil extended-release capsules for Alzheimer's-related dementia, with an exclusive 180-day marketing period. Additionally, everolimus tablets for oral suspension have been released to treat Tuberous Sclerosis Complex-associated tumors, broadening options in a market with few suppliers.
The FDA has also granted tentative approval to Amneal's rifaximin 550 mg oral tablets for adults with irritable bowel syndrome with diarrhea (IBS-D), a product currently involved in litigation. This tentative status indicates that final approval is contingent upon the resolution of legal challenges.
Amneal's memantine/donepezil capsules are indicated for moderate to severe dementia related to Alzheimer's disease. The most common adverse reactions reported include headache, diarrhea, and dizziness. Everolimus tablets are prescribed for the treatment of certain brain tumors associated with Tuberous Sclerosis Complex, with stomatitis and respiratory tract infections as the most frequently observed adverse reactions.
The company's Executive Vice President, Andy Boyer, highlighted the importance of these approvals, stating that they expand Amneal's differentiated portfolio and provide new essential therapies to customers, providers, and patients.
According to data from IQVIA, U.S. annual sales for the three drugs memantine/donepezil, everolimus, and rifaximin, for the 12 months ending November 2024, were approximately $88 million, $114 million, and $2.6 billion, respectively. The company's stock has shown strong momentum, delivering a 55% return over the past year, while revenue grew by 12.3% in the last twelve months. InvestingPro analysis suggests the stock is currently fairly valued, with additional ProTips available for subscribers.
This announcement is based on a press release statement from Amneal Pharmaceuticals, a global biopharmaceutical company known for its diverse portfolio of over 280 generic and specialty pharmaceuticals. The company's focus remains on innovation across various complex product categories and therapeutic areas, including injectables and biosimilars, as well as a growing portfolio of branded pharmaceuticals primarily targeting central nervous system and endocrine disorders. Analysts expect strong performance ahead, with revenue forecast to grow by 16% in FY2024. For detailed analysis and additional insights, investors can access the comprehensive Pro Research Report available on InvestingPro, which covers this and 1,400+ other top US stocks.
In other recent news, Amneal Pharmaceuticals has made significant strides in its product lineup, with the resubmission of a New Drug Application for its dihydroergotamine autoinjector and the FDA approval for exenatide, a generic injectable for type 2 diabetes mellitus. These developments have been accompanied by robust third-quarter financial results, with the company reporting adjusted diluted earnings per share of $0.16 on revenues of $702 million. This strong performance has led Piper Sandler to upgrade its stock price target for Amneal from $9.00 to $11.00.
Additionally, Amneal's strategic initiatives, such as the launch of CREXONT for Parkinson's disease and a partnership with Metsera for obesity treatment, have contributed to a 13% increase in revenue. The company's revenue from affordable medicines also grew by 12%, contributing an additional $35 million due to new product launches.
Looking ahead, Amneal has confirmed its revenue and adjusted EBITDA guidance for 2024, projecting ranges of $2.7 billion to $2.8 billion and $610 million to $630 million, respectively. The company also anticipates healthcare distribution revenues to exceed $700 million by 2025, with international expansion adding an additional $50-100 million by 2027. These projections indicate clear prospects for sustained growth, as noted by Piper Sandler.
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