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) 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.
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Amneal Pharmaceuticals (NYSE: AMRX) has launched LYVISPAH, a new baclofen oral granule product approved by the FDA for spasticity associated with multiple sclerosis and spinal cord disorders. Available in 5mg, 10mg, and 20mg packets, LYVISPAH offers flexible dosing options, addressing difficulties some patients face when swallowing pills. This marks Amneal’s first specialty product launch since 2015 and aligns with its strategy to expand its specialty business. The U.S. market for baclofen generated $130 million in annual sales for the year ending March 2022.
Amneal Pharmaceuticals (NYSE: AMRX) recently announced FDA approval for FYLNETRA (pegfilgrastim-pbbk), a biosimilar to Neulasta®, marking its third biosimilar approval in 2022. Developed in partnership with Kashiv Biosciences, FYLNETRA is intended to treat neutropenia in chemotherapy patients. This approval further solidifies Amneal's position in the $28 billion U.S. biosimilars market, where annual pegfilgrastim sales reached $3.1 billion. The company plans to launch FYLNETRA along with its other biosimilars later this year.
Amneal Pharmaceuticals, Inc. (NYSE: AMRX) announced participation in the 2022 Jefferies Healthcare Conference on June 8, 2022, in New York City. Co-CEO Chirag Patel and CFO Tasos Konidaris will represent the company, with Patel hosting a presentation at 8:00 AM ET. A live webcast of the presentation will be available on the Investor Relations section of their website, followed by a replay accessible for 90 days. Amneal specializes in generic and specialty pharmaceuticals, focusing on essential medicines and a diverse product portfolio.
Amneal Pharmaceuticals (NYSE: AMRX) will participate in several investor conferences, including the RBC Healthcare Conference on May 17, 2022, and the UBS Healthcare Conference on May 25, 2022, both in New York City. Additionally, the company will feature in the Barclays CEO Call Series on May 27, 2022, at 10:00 AM Eastern Time. As a fully-integrated essential medicines company, Amneal specializes in generic and specialty pharmaceuticals with a diverse portfolio of over 250 products. For more information, visit www.amneal.com.
Amneal Pharmaceuticals (AMRX) reported Q1 2022 net revenue of $498 million, a 1% increase from Q1 2021. The company faced a net loss of $2 million compared to a net income of $7 million last year. Adjusted EBITDA was $100 million, down 13% year-over-year, and adjusted diluted EPS was $0.12, down from $0.17. Despite challenges, Amneal maintains its 2022 financial outlook with net revenue guidance of $2.15 billion - $2.25 billion and adjusted EBITDA of $540 million - $560 million.
Amneal Pharmaceuticals (NYSE: AMRX) has received FDA approval for ALYMSYS®, a biosimilar referencing Avastin®, marking the second of three oncology biosimilar approvals expected in 2022. Developed in partnership with mAbxience, ALYMSYS® addresses a $2.6 billion market, with $1.6 billion from biosimilars alone. This product targets various cancers, enhancing Amneal's position in the growing U.S. biosimilars market, estimated at $28 billion. The company's strategic focus aims to deliver affordable medicines to patients while continuing to innovate within the pharmaceutical landscape.
Amneal Pharmaceuticals, Inc. (NYSE: AMRX) will announce its first quarter 2022 financial results on May 4, 2022, before the market opens. A conference call and live webcast with investors will occur at 8:30 a.m. Eastern Time the same day. Investors can access the financial results and the webcast on the company’s Investor Relations website. For those wishing to join the call, U.S. participants can dial (844) 200-6205 and international callers can use (929) 526-1599, with access code 874223.
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