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 (AMRX) generates news primarily through FDA regulatory decisions, product launch announcements, and financial performance disclosures. As a pharmaceutical company focused on generics and biosimilars, Amneal's news flow centers on drug approval milestones that directly impact its product portfolio and revenue potential.
The company announces FDA approvals for generic medications and biosimilar candidates, which represent the culmination of multi-year development programs and regulatory review processes. These approvals determine when Amneal can commercialize new products and enter markets previously dominated by brand-name drugs. Product launch announcements reveal the company's commercial strategy and competitive positioning within specific therapeutic categories.
Earnings reports provide visibility into Amneal's financial performance across its generics and specialty segments, though these documents often include forward-looking statements and time-sensitive metrics. The company also discloses material events through regulatory filings when significant business developments occur, such as manufacturing facility inspections, patent litigation outcomes, or strategic partnerships.
For pharmaceutical investors, Amneal's news coverage offers insights into the company's pipeline progression, regulatory success rates, and ability to navigate the complex approval process for generic and biosimilar products. The FDA approval announcements are particularly significant as they determine the timing and exclusivity status of new product launches in the competitive pharmaceutical market.
Amneal Pharmaceuticals (NASDAQ: AMRX) announced expanded insurance coverage for CREXONT®, its Parkinson's disease treatment, with three major insurers: Veterans Administration, UnitedHealthcare, and CVS Health. This expansion increases total U.S. coverage from 30% to over 50% of covered lives, achieved nine months ahead of their end-2025 target.
CREXONT, FDA-approved in August 2024, combines immediate-release granules with extended-release pellets, making it the longest-lasting oral carbidopa/levodopa formulation available. Clinical trials demonstrated 1.55 more hours of 'Good On' time per dose compared to immediate-release alternatives, representing a 70% increase in symptom control time.
The coverage rollout includes: VA's immediate national formulary addition (covering ~10% of U.S. PD patients), UnitedHealthcare's addition in Q2 2025, and CVS Health's inclusion as a 'preferred' product starting July 1, 2025.
Amneal Pharmaceuticals (NASDAQ: AMRX) has launched BORUZU™, the first ready-to-use subcutaneous formulation of bortezomib for treating multiple myeloma and mantle cell lymphoma in the U.S. This innovative product, developed in partnership with Shilpa Medicare , eliminates the need for traditional compounding preparation steps required with administration.
BORUZU™ references the branded product Velcade® but comes as a ready-to-use injection instead of a lyophilized powder requiring reconstitution. The product features a unique J-code to facilitate reimbursement and represents Amneal's fourth 505(b)(2) injectable product launch in the past year.
Under the partnership agreement, Shilpa developed the molecule while Amneal will handle manufacturing and commercialization. Common adverse reactions reported in clinical studies include asthenic conditions, diarrhea, nausea, peripheral neuropathy, and various blood-related conditions.
Amneal Pharmaceuticals (Nasdaq: AMRX) has announced its participation in the Barclays 27th Annual Global Healthcare Conference. The event will feature Co-Chief Executive Officer and President Chirag Patel in a fireside chat scheduled for March 12, 2025, at 11:00 AM ET.
Investors and interested parties can access a live webcast of the presentation through the company's investor relations website at https://investors.amneal.com. A replay option will be made available after the event concludes.
Amneal Pharmaceuticals (AMRX) announced FDA acceptance of Biologics Licensing Applications (BLA) for two denosumab biosimilar candidates referencing Prolia® and XGEVA®. The FDA's target action date is set for Q4 2025.
The biosimilars are developed through a partnership with mAbxience, where mAbxience handles development and manufacturing while Amneal manages regulatory approval and U.S. commercialization. These candidates represent Amneal's next potential biosimilar launches, adding to their current portfolio of three commercialized biosimilars.
Denosumab is a monoclonal antibody that inhibits bone reabsorption, used for bone metastasis from cancer and prevention of bone-related injuries including osteoporosis. The U.S. market for Prolia® and XGEVA® reached approximately $5.0 billion in annual sales for the 12 months ended December 2024.
Amneal aims to expand its portfolio to six biosimilars across eight product presentations by 2027, strengthening its position in the U.S. biosimilars market.
Amneal Pharmaceuticals (AMRX) reported strong Q4 and full-year 2024 results, meeting or exceeding all financial guidance metrics. Q4 net revenue reached $731 million, up 18% year-over-year, with a GAAP net loss of $31 million ($0.10 per share). Full-year 2024 revenue was $2.79 billion, representing 17% growth, though the company recorded a net loss of $117 million ($0.38 per share).
All three business segments achieved double-digit growth in 2024: Affordable Medicines (+15%), AvKARE (+25%), and Specialty (+14%). The company successfully reduced net leverage to 3.9x, one year ahead of schedule. For 2025, Amneal projects net revenue between $3.0-$3.1 billion and Adjusted EBITDA of $650-$675 million, focusing on expansion in Specialty, Biosimilars, and GLP-1 therapies.
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.
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