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. reports developments across a diversified pharmaceutical business built around Affordable Medicines, Specialty and AvKARE. Its updates commonly cover U.S. launches of complex generics, injectables, biosimilars and other affordable medicines, including respiratory inhalation and ophthalmic products, as well as branded specialty treatments in neurology and endocrinology.
News about AMRX also includes clinical and regulatory disclosures for products such as CREXONT for Parkinson’s disease, financial results, capital-structure updates, material agreements and governance matters. AvKARE-related updates center on distribution of pharmaceuticals and medical products to U.S. federal, retail and institutional customers.
Amneal (NASDAQ: AMRX) announced the completion of its acquisition of Kashiv BioSciences on August 10, 2026, creating what the company describes as a fully integrated global biosimilars platform. The combined business now spans biosimilar research and development, manufacturing and commercialization, positioning biosimilars as a major long-term growth pillar within Amneal’s Affordable Medicines segment.
According to Amneal, the transaction gives the company access to the global biosimilars market, supported by more than $300 billion in projected global biologics loss-of-exclusivity over the next decade. Management expects the integrated platform and combined portfolio to support a consistent cadence of biosimilar launches for years, extending Amneal’s growth profile into the 2030s. Integration efforts are underway, focused on aligning development and manufacturing capabilities and advancing the biosimilar pipeline, building on the companies’ decade-long relationship.
Amneal Pharmaceuticals (Nasdaq: AMRX) reported Q2 2026 net revenue of $796 million, up 10% year over year, with GAAP net income of $58 million and diluted EPS of $0.18. Adjusted EBITDA was $206 million and adjusted diluted EPS was $0.30, up 12% and 20%, respectively.
Specialty net revenue grew 17%, Affordable Medicines grew 13%, while AvKARE declined 4%. In July, Amneal repriced its $2.084 billion Term Loan B, cutting the margin by 50 bps and targeting about $12 million in annual interest savings, and plans an additional $350 million Term Loan B to help fund the pending Kashiv Biosciences acquisition.
The company raised 2026 guidance: net revenue to $3.10–$3.20 billion, adjusted EBITDA to $750–$780 million, and adjusted diluted EPS to $0.96–$1.06. Capital expenditure guidance increased to about $150 million from about $110 million.
Amneal (Nasdaq: AMRX) announced U.S. FDA approval of additional strengths and vial sizes of its iohexol injection: 350 mg iodine/mL in 50 mL, 75 mL and 100 mL vials, and 300 mg iodine/mL in 50 mL vials. Amneal plans to launch these products in the third quarter of 2026.
These new presentations complement the company’s previously approved 300 mg iodine/mL 100 mL vial, creating a broader iohexol portfolio intended to address the majority of U.S. market demand across key presentations and to offer hospitals, imaging centers and healthcare providers more flexibility and supply options. According to Amneal, these are the first generic versions referencing OMNIPAQUE™ across the approved presentations. Iohexol is a radiographic contrast agent for multiple imaging routes in adults and pediatric patients two weeks and older, and carries a boxed warning for serious adverse reactions with intrathecal use at the wrong iodine concentration. IQVIA® estimates U.S. iohexol injection sales at approximately $706 million for the 12 months ended May 2026.
Amneal (NASDAQ:AMRX) will report second quarter 2026 financial results on Thursday, July 30, 2026, before the market opens. The company will host an audio webcast at 8:30 a.m. ET, accessible via the Investor Relations section of its website.
Amneal (NASDAQ:AMRX) and Zambon announced a positive CHMP opinion recommending EMA marketing authorization for Hopledo (IPX203), a modified-release levodopa/carbidopa for adults with Parkinson’s disease and moderate to severe motor fluctuations.
The opinion is based on Phase 3 RISE-PD data showing significantly more “Good ON” time versus immediate-release LD/CD with fewer daily doses and a comparable safety profile. Hopledo, already sold in the US as CREXONT, could be introduced across Europe from October 2026 if the European Commission grants approval.
Amneal (NYSE:AMRX) is an early manufacturing partner in Dispensary of Hope’s new national “Hope Alliance” campaign, aimed at expanding access to longer-dated, high-quality medications for low-income and uninsured patients. Amneal has made a significant planned-giving commitment to support a reliable supply of chronic care therapies.
The initiative shifts from surplus, short-dated donations to contributions from current production, intended to stabilize supply, improve adherence, support safety-net clinics, and foster health equity for uninsured patients served nationwide.
Amneal (Nasdaq: AMRX) reported interim Phase 4 ELEVATE-PD results in 214 Parkinson's patients switched to CREXONT for six weeks. Across prior regimens, patients gained about 3.0–3.3 hours of daily “Good On” time, cut “Off” time by up to 3.2 hours, and improved MDS-UPDRS motor scores.
Among RYTARY switchers, continuous “Good On” nearly doubled to 6.27 hours and daily motor fluctuations fell 42.8%. Adverse events were mostly mild to moderate. In May 2026, the FDA approved a label update allowing CREXONT capsule contents to be sprinkled on applesauce.
Amneal (Nasdaq: AMRX) received U.S. FDA approval for its romidepsin injection solution, 27.5 mg/5.5 mL, in ready-to-use single-dose vials. The product is eligible for Competitive Generic Therapy (CGT) designation, providing 180 days of market exclusivity.
The drug is a histone deacetylase inhibitor indicated for adult cutaneous T-cell lymphoma patients after at least one prior systemic therapy. According to IQVIA, U.S. annual sales for romidepsin lyophilized powder were about $78 million for the 12 months ended April 2026.
Amneal (Nasdaq: AMRX) announced that Co-Chief Executive and President Chirag Patel will present at the Goldman Sachs 47th Annual Global Healthcare Conference 2026 in Miami, FL. The company presentation is scheduled for Tuesday, June 9, 2026, at 8:40 AM EDT.
Amneal (NASDAQ: AMRX) reported Q1 2026 net revenue $723M, GAAP net income $62M and diluted EPS $0.19; adjusted EBITDA was $202M and adjusted diluted EPS was $0.27. Specialty revenue rose 23%; Affordable Medicines rose 2%.
The company affirmed its raised 2026 guidance: net revenue $3.05B–$3.15B, adjusted EBITDA $740M–$770M, adjusted diluted EPS $0.95–$1.05, and operating cash flow $350M–$400M.