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 announced the presentation of topline results from its pivotal Phase 3 RISE-PD trial for IPX-203, a novel CD/LD formulation for Parkinson's disease, at the American Academy of Neurology Annual Meeting from April 2-7, 2022, in Seattle, WA. The trial demonstrated significant improvement in "Good On" time per dose, indicating potential benefits in symptom control. A New Drug Application is planned for submission in Q2 2022. The study involved 506 patients across 105 sites in the U.S. and Europe, showcasing Amneal's commitment to advancing Parkinson's treatments.
Amneal Pharmaceuticals (NYSE: AMRX) has secured a sub-license from the Medicines Patent Pool (MPP) to manufacture and commercialize a generic version of nirmatrelvir, co-packaged with ritonavir, in 95 low- and middle-income countries. This oral protease inhibitor, marketed as PAXLOVIDTM by Pfizer, has shown an 89% reduction in COVID-19-related hospitalizations. Amneal aims to produce nirmatrelvir in India and utilize its FDA-approved generic ritonavir from both India and the U.S., potentially delivering hundreds of millions of doses to impacted populations.
Amneal Pharmaceuticals (NYSE: AMRX) reported Q4 2021 net revenue of $537 million, a 5% increase from Q4 2020, despite a GAAP net loss of $6 million. Full year net revenue reached $2.1 billion, up 5% year-over-year, with a GAAP net income of $11 million. Adjusted figures showed significant growth, including Adjusted Net Income of $258 million and Adjusted EBITDA of $538 million for 2021. For 2022, the company expects net revenue between $2.15 billion and $2.25 billion and adjusted EBITDA of $540 million to $560 million.
Amneal Pharmaceuticals (NYSE: AMRX) received FDA approval for RELEUKO™, a biosimilar to Neupogen®, targeting neutropenia treatment. Developed with Kashiv Biosciences, this marks Amneal's first biosimilar launch, anticipated in Q3 2022. The U.S. market for filgrastim saw annual sales of
Amneal Pharmaceuticals, Inc. (NYSE: AMRX) has received FDA approval for four generic injectable products: Dexamethasone, Azacitidine, Carboprost, and Atropine. This strategic move aims to bolster Amneal's position in the U.S. institutional injectables market, addressing drug shortages of Dexamethasone and Azacitidine. Collectively, the annual sales of these products were approximately $184 million for the year ending December 2021. Amneal plans to expand its injectables portfolio, targeting over 40 launches by 2025, focusing on complex therapeutic areas.
Amneal Pharmaceuticals, Inc. (NYSE: AMRX) announced it will release its fourth quarter and full year 2021 financial results on March 2, 2022, before market open. A conference call will follow at 8:30 a.m. Eastern Time on the same day, accessible via the Investor Relations section of the Company’s website. Investors can dial (844) 200-6205 in the U.S. or (929) 526-1599 internationally to join the call. A replay will be available for seven days after the call. Amneal is a fully-integrated essential medicines company, focusing on generics and specialty pharmaceuticals.
Amneal Pharmaceuticals (NYSE: AMRX) has announced the acquisition of Saol Therapeutics' Baclofen franchise, which includes Lioresal and LYVISPAH, for approximately
Amneal Pharmaceuticals, Inc. (NYSE: AMRX) announced that Co-CEO Chirag Patel will present at the 40th Annual J.P. Morgan Healthcare Conference on January 12, 2022, at 11:15 AM ET. The event will be accessible via a live webcast through the Company’s Investor Relations website, with a replay available for 30 days post-event. Amneal is focused on developing, manufacturing, and distributing generic and specialty pharmaceuticals, with a broad product portfolio across various therapeutic areas. The Company's growth strategy includes expanding its offerings, particularly in injectables and biosimilars.
Amneal Pharmaceuticals (NYSE: AMRX) has received FDA approval for its generic ophthalmic product, difluprednate ophthalmic emulsion 0.05%, a substitute for Durezol®, used to treat pain and inflammation from ocular surgery. This product marks a strategic shift towards more complex offerings in Amneal's portfolio. The annual sales for Durezol® and generics stand at approximately $103 million as of September 2021. However, potential side effects include increased risks of cataracts and glaucoma.
Amneal Pharmaceuticals, Inc. (NYSE: AMRX) will participate in three upcoming investor conferences. The Jefferies London Healthcare Conference is scheduled for November 18, 2021. The Goldman Sachs Global Sustainability Forum will take place on November 30, 2021. Additionally, Amneal will present at the Evercore ISI 4th Annual HEALTHCONx Virtual Conference on December 1, 2021, with a presentation starting at 8:25 AM Eastern Time. A live webcast will be available on the company's Investor Relations website.
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