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 global biopharmaceutical company headquartered in Bridgewater, New Jersey, with news flow that reflects activity across its Affordable Medicines, Specialty, and AvKARE segments. This page aggregates company-specific coverage so readers can follow how Amneal’s development, manufacturing, and distribution efforts translate into regulatory milestones, clinical results, and financial performance.
News about Amneal frequently centers on U.S. FDA approvals and regulatory updates. Recent announcements include approvals for denosumab biosimilars referencing Prolia and XGEVA, epinephrine injection in single- and multi-dose vials for hospitals, iohexol injection as a first generic version of Omnipaque, albuterol sulfate inhalation aerosol as a generic equivalent of PROAIR HFA, and cyclosporine ophthalmic emulsion 0.05% as a generic equivalent of RESTASIS. These items illustrate the company’s focus on complex injectables, biosimilars, respiratory therapies, and ophthalmic products within its Affordable Medicines segment.
In the Specialty segment, news coverage highlights branded CNS and endocrine therapies, particularly CREXONT for Parkinson’s disease. Amneal has reported positive interim Phase 4 ELEVATE-PD results and emphasizes CREXONT’s role in improving motor symptom control and "Good On" time. The company also reports on collaborations, such as a research collaboration and option agreement with KeifeRx to advance KFRX06, a brain-penetrant LRRK2 program for Parkinson’s disease.
Investors and analysts will also find financial results and capital markets updates, including quarterly earnings releases, guidance updates, and details of term loan and senior secured notes financings. Governance and corporate events, such as participation in healthcare investor conferences and board changes, are disclosed through press releases and Form 8-K filings.
For users tracking AMRX, this news feed provides a centralized view of regulatory decisions, product launches, clinical data, financing transactions, and strategic collaborations that shape Amneal’s business across its three segments.
Amneal Pharmaceuticals (NYSE: AMRX) has appointed Reem Malki as Senior Vice President, Chief Quality Officer, and Maryll W. Toufanian as Senior Vice President, Regulatory Strategy and Policy. Malki brings over 30 years of experience from Alvotech and Mylan, focusing on quality operations in biosimilars. Toufanian, an FDA veteran, previously directed the Office of Generic Drug Policy. These leadership appointments aim to enhance Amneal's capabilities in biosimilars, complex generics, injectables, and specialty areas, signaling a strategic expansion in high-growth sectors.
Amneal Pharmaceuticals, Inc. (NYSE: AMRX) will release its third quarter 2022 financial results on November 4, 2022, before market open. A conference call and live webcast for investors will follow at 8:30 a.m. Eastern Time. Access to the financial results and the live webcast is available on the Investor Relations section of the website. Callers can join by dialing 1 (844) 200-6205 or 1 (929) 526-1599 for international access, using access code 585341.
A replay will be available shortly after the call.
Amneal Pharmaceuticals (NYSE: AMRX) has launched ALYMSYS® (bevacizumab-maly), a new oncology biosimilar referencing Avastin®. This marks Amneal's entry into the rapidly growing $28 billion U.S. biosimilars market. ALYMSYS® aims to enhance access to affordable oncology treatments, especially given that the annual sales for bevacizumab reached $2.4 billion as of July 2022. The company plans to expand its biosimilars portfolio in the future, aligning with its mission for affordable medicines.
Amneal Pharmaceuticals, Inc. (NYSE: AMRX) announced the appointment of Gustavo Pesquin as Executive Vice President, Chief Commercial Officer - Specialty, effective September 6, 2022. Pesquin joins from Sanofi, bringing over 11 years of leadership experience, including roles as North America Head for General Medicines. His expertise is expected to enhance Amneal's growth in the Specialty segment, which focuses on central nervous system and endocrine disorders. The Co-CEOs expressed confidence that his diverse background will drive the company’s next phase of growth.
Amneal Pharmaceuticals has submitted a New Drug Application (NDA) to the FDA for IPX203, an extended-release formulation of carbidopa/levodopa aimed at improving treatment for Parkinson's disease. Results from the Phase 3 RISE-PD trial showed IPX203 provided an average of 1.55 more hours of 'Good On' time compared to immediate-release formulations, despite being taken less frequently. The formulation aims to address the needs of Parkinson's patients for enhanced motor control and less frequent dosing.
Amneal Pharmaceuticals (NYSE: AMRX) announced its support for the newly formed Congressional Domestic Pharmaceutical Manufacturing Caucus, aimed at ensuring a resilient supply chain of essential medicines manufactured in the U.S.. The caucus, led by a bipartisan group of representatives, seeks to address supply chain vulnerabilities highlighted by the pandemic and geopolitical conflicts. Co-CEOs Chirag and Chintu Patel emphasized the importance of domestic manufacturing for national security and aim for legislative solutions to drive change in pharmaceutical supply chains.
Amneal Pharmaceuticals (NYSE: AMRX) has received FDA approval for four generic products, expanding its essential medicines portfolio. The approved products include vasopressin injection, famotidine for oral suspension, atropine sulfate ophthalmic solution, and clindamycin phosphate topical gel. Together, these products represent a market potential of approximately $784 million. Amneal aims to launch 20-30 generics annually, with this latest approval bringing their year-to-date launches to 16. This strategic move is expected to enhance their position in the generics market.
Amneal Pharmaceuticals (AMRX) reported Q2 2022 net revenue of $559 million, up 5% from Q2 2021. However, the company faced a net loss of $121 million, primarily due to a $263 million charge for antitrust litigation. Adjusted EBITDA was $135 million, a decrease of 6%. Diluted loss per share stood at $(0.80), while adjusted diluted EPS was $0.19. The company revised its 2022 guidance, projecting net revenue of $2.15 billion to $2.25 billion and adjusted EBITDA of $500 million to $520 million.
Amneal Pharmaceuticals (NYSE: AMRX) appointed Deborah M. Autor as a new independent director on July 29, 2022. Autor brings extensive expertise in the biopharmaceutical industry, particularly in quality, regulatory affairs, and policy. Her background includes key roles at AstraZeneca and Mylan N.V., as well as significant experience with the FDA, where she served as Deputy Commissioner. The addition of Autor aims to strengthen Amneal's leadership as the company targets growth in complex pharmaceutical markets.
Amneal Pharmaceuticals, Inc. (NYSE: AMRX) will release its second quarter 2022 financial results on August 5, 2022, before market open. A conference call and live webcast will occur at 8:30 a.m. Eastern Time the same day, accessible via the Investor Relations section of Amneal's website. Interested parties can join the call by dialing 1 (844) 200-6205 (U.S.) or 1 (929) 526-1599 (international), using access code 236256. A replay will be available after the call. Amneal is a fully integrated essential medicines company, producing over 250 products.
FAQ
What is the current stock price of Amneal Pharmaceuticals (AMRX)?
What is the market cap of Amneal Pharmaceuticals (AMRX)?
