Welcome to our dedicated page for Amneal Pharmaceuticals news (Ticker: AMRX), a resource for investors and traders seeking the latest updates and insights on Amneal Pharmaceuticals stock.
Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) is a leading global pharmaceutical company headquartered in Bridgewater, NJ. Amneal develops, manufactures, and distributes a diverse portfolio of over 280 generic and specialty pharmaceutical products across the United States, India, and Ireland. With a commitment to providing affordable medicines, Amneal operates through three key segments: Generics, Specialty, and AvKARE.
Generics Segment: This segment focuses on producing a wide range of dosage forms and delivery systems, including injectables and biosimilars, contributing significantly to the company's revenue. The Generics segment is dedicated to expanding across complex product categories and therapeutic areas, ensuring patients have access to vital medications.
Specialty Segment: Amneal's Specialty segment promotes proprietary branded pharmaceuticals targeting central nervous system and endocrine disorders. The segment has a growing portfolio of branded pharmaceuticals with a pipeline focused on addressing unmet medical needs, demonstrating the company's commitment to innovation.
AvKARE Segment: This segment distributes pharmaceuticals and medical products to governmental agencies, specializing in re-packaging and wholesale distribution. AvKARE focuses on offering consistent care and pricing to qualified entities, enhancing access to essential medicines for governmental and institutional markets.
Recently, Amneal has achieved significant milestones, including the resubmission of a Complete Response to the FDA for IPX203, an oral formulation for Parkinson’s disease, and entering a licensing agreement with Zambon Biotech for IPX203 in Europe. The company also launched PEMRYDI RTU®, the first ready-to-use version of pemetrexed for injection, underscoring their commitment to oncology treatment advancements.
Amneal's financial performance remains robust, with net revenue of $2.39 billion in 2023 and a strategic focus on expanding its reach through innovative products and international partnerships. The company continuously invests in research and development to meet the growing demands for affordable and high-quality medications, solidifying its position as a key player in the pharmaceutical industry. For more information, please visit www.amneal.com.
Amneal Pharmaceuticals (AMRX) has announced two significant developments: the launch of mesalamine 800 mg delayed-release tablets for treating moderately active ulcerative colitis in adults, and FDA approval for lenalidomide capsules in multiple strengths. Mesalamine represents a complex product with market suppliers, while lenalidomide will be available for sale starting January 31, 2026, following a settlement with Celgene.
The mesalamine market shows significant potential, with U.S. annual sales reaching approximately $147 million for the 12 months ended December 2024. The company views these developments as key drivers for sustainable business growth, particularly highlighting their R&D capabilities in complex drug manufacturing.
Amneal Pharmaceuticals (NASDAQ: AMRX) has announced it will release its fourth quarter and full year 2024 financial results on Friday, February 28, 2025, before market open. The company will host an audio webcast at 8:30 a.m. ET on the same day.
Investors can access the financial results and live webcast through the company's Investor Relations website at https://investors.amneal.com. The conference call can be accessed by dialing 1 (833) 470-1428 in the U.S., with the access code 863159. A replay will be available after the call.
Amneal Pharmaceuticals (AMRX) has received FDA approval for two products and one tentative approval: memantine/donepezil extended-release capsules for Alzheimer's dementia treatment (with 180-day exclusivity), everolimus tablets for treating Tuberous Sclerosis Complex, and tentative approval for rifaximin tablets for IBS-D treatment.
The memantine/donepezil product references Abbvie's NAMZARIC®, everolimus references Novartis' AFINITOR DISPERZ®, and rifaximin references Bausch Health's XIFAXAN®. The U.S. market size for these products (as of November 2024) is approximately $88 million for memantine/donepezil, $114 million for everolimus, and $2.6 billion for rifaximin (all indications).
Amneal Pharmaceuticals (Nasdaq: AMRX) has announced its participation in two major upcoming investor conferences. Chirag Patel, Co-Chief Executive Officer and President, and Tasos Konidaris, Chief Financial Officer, will represent the company.
The first event is the 36th Annual Piper Sandler Healthcare Conference in New York on December 4, 2024, featuring a fireside chat at 11:00 AM EST. The second is the 43rd Annual J.P. Morgan Healthcare Conference in San Francisco from January 13-15, 2025, with a presentation scheduled for January 15 at 10:30 AM PST.
Both events will be accessible via live webcast on Amneal's investor relations website, with replays available afterward.
Amneal Pharmaceuticals (AMRX) announced two major developments: the resubmission of its NDA for a DHE autoinjector for migraine and cluster headache treatment, and FDA approval of exenatide, its first generic injectable GLP-1 agonist. The DHE autoinjector would be the first and only of its kind, offering at-home self-administration without refrigeration or assembly. The FDA review is expected by Q2 2025. The exenatide approval (1.2 mL and 2.4 mL prefilled pens) demonstrates Amneal's capabilities in complex pharmaceuticals and peptide development, targeting type 2 diabetes treatment.
Amneal Pharmaceuticals (AMRX) reported Q3 2024 financial results with net revenue of $702 million, up 13% year-over-year. The company posted a GAAP net loss of $0.2 million and adjusted EBITDA of $158 million. Generics revenue increased 9%, Specialty revenue grew 19%, and AvKARE revenue rose 21%. Key developments include the launch of CREXONT® for Parkinson's disease, collaboration with Metsera for obesity medicines, and in-licensing of a new biosimilar. The company affirmed its 2024 full-year guidance with projected net revenue of $2.70-2.80 billion and adjusted EBITDA of $610-630 million.
Amneal Pharmaceuticals (Nasdaq: AMRX) has received FDA approval for its New Drug Application (NDA) for Pyridostigmine Bromide Extended-Release (PB ER) Tablets USP 105 mg. This once-daily product is designed for pretreatment against soman nerve agent poisoning in adults, specifically for the U.S. Armed Services and allies. Developed using Amneal's GRANDE® drug delivery technology, it offers potential for improved compliance and steady 24-hour release, replacing the current thrice-daily dosing regimen.
The project was partially funded by the U.S. government under Agreement W911QY-21-9-0018. This marks Amneal's second NDA approval this year, following CREXONT for Parkinson's disease. The most common serious adverse reactions reported were breathing difficulties, dizziness, and loss of consciousness.
Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) has announced that it will release its third quarter 2024 financial results on Friday, November 8, 2024, before the market opens. The company will host a conference call and live webcast with the investment community at 8:30 a.m. Eastern Time on the same day.
Investors can access the financial results and live webcast through the Investor Relations section of Amneal's website at https://investors.amneal.com. To join the webcast, individuals can register using the provided link. For those who prefer to join via phone, the U.S. dial-in number is 1 (833) 470-1428, with international numbers available through a separate link. The access code for the call is 088741.
A replay of the conference call will be made available shortly after the event and will remain accessible for seven days.
Amneal Pharmaceuticals (AMRX) and Metsera have announced a strategic collaboration to develop and supply next-generation medicines for obesity and metabolic diseases. Key points include:
1. Amneal will construct new manufacturing facilities in India for peptide synthesis and sterile fill-finish, with a net cost of $150-200 million over 4-5 years.
2. Metsera is advancing a portfolio of therapies, including ultra-long acting injectable and oral nutrient stimulated hormone (NuSH) analogs.
3. Amneal will be Metsera's preferred supply partner for developed markets and gain commercialization rights in select emerging markets.
4. The collaboration aims to deliver weight loss medicines at scale, leveraging Amneal's manufacturing expertise and Metsera's innovative drug portfolio.
Amneal Pharmaceuticals (Nasdaq: AMRX) has launched CREXONT® (carbidopa and levodopa) extended-release capsules for Parkinson's disease treatment. CREXONT® is now available in U.S. pharmacies nationwide. The novel formulation combines immediate-release granules and extended-release pellets, providing longer duration of "Good On" time with less frequent dosing compared to immediate-release CD/LD.
Amneal is implementing a comprehensive education program and extensive services to support healthcare providers and patients. Eligible commercially insured patients may qualify for a $25 copay through the CREXONT Savings Program. The company will also offer patient assistance and prior authorization support.
Amneal will present CREXONT at the International Congress of Parkinson's Disease and Movement Disorders on Sept. 27 – Oct. 1, 2024, including a launch symposium and scientific presentations.
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