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 (NYSE: AMRX) delivers essential medicines through its focus on affordable generics and specialty pharmaceuticals. This news hub provides investors and healthcare professionals with timely updates on regulatory developments, strategic partnerships, and operational milestones.
Our curated collection features official press releases and verified news coverage spanning key business segments. Track updates on generic drug approvals, manufacturing expansions, and AvKARE distribution network enhancements. Access filings related to FDA submissions, intellectual property developments, and corporate governance matters.
Discover comprehensive coverage of earnings announcements, research collaborations, and therapeutic area advancements. The resource serves as an objective reference for monitoring AMRX's role in improving medication accessibility while maintaining quality standards across global markets.
Bookmark this page for streamlined access to Amneal's latest developments in generic pharmaceuticals and complex drug formulations. Regularly updated content supports informed analysis of this NYSE-listed company's market position and industry contributions.
Amneal Pharmaceuticals (Nasdaq: AMRX) has announced a significant $1.5 million donation to multiple patient assistance foundations supporting individuals with Parkinson's disease during Parkinson's Awareness Month.
The donation aims to help offset out-of-pocket costs, including copayments, coinsurance, and deductibles for FDA-approved Parkinson's medications. This initiative addresses the financial challenges faced by over 10 million people worldwide affected by this progressive disease.
Joe Renda, Senior Vice President, Chief Commercial Officer – Specialty at Amneal, emphasized that access to medication shouldn't be a barrier for Parkinson's patients. The company's contribution focuses on breaking down financial obstacles and improving treatment accessibility to help patients live fuller, more empowered lives.
Amneal Pharmaceuticals (NASDAQ: AMRX) has scheduled the release of its first quarter 2025 financial results for Friday, May 2, 2025, before market open. The company will host an audio webcast at 8:30 a.m. ET on the same day.
Investors and interested parties can access the webcast through the company's Investor Relations website at https://investors.amneal.com. For those preferring a conference call, dial-in options are available at 1 (833) 470-1428 for U.S. participants, with international numbers also provided. The access code for the call is 170097.
Amneal Pharmaceuticals (AMRX) has announced new Phase 3 study data demonstrating significant improvements in sleep quality for Parkinson's disease patients using CREXONT® (Carbidopa and Levodopa) Extended-Release Capsules.
The RISE-PD study analysis revealed that patients who converted from immediate release (IR) carbidopa/levodopa to CREXONT showed statistically significant improvements in Parkinson's Disease Sleep Scale-2 (PDSS-2) scores, with a mean difference of -2.35 (p<0.0001). Patients experienced improvements across all PDSS-2 subdomains, including reduced disturbed sleep (-1.07), improved nighttime motor symptoms (-0.62), and PD symptoms at night (-0.65).
A separate analysis showed that CREXONT treatment resulted in more patients waking up in an 'On' state compared to IR CD/LD patients. Amneal has initiated a Phase 4 trial, ELEVATE-PD, to evaluate real-world efficacy and safety. The most common adverse reactions with CREXONT were nausea and anxiety.
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.
