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 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.
Amneal Pharmaceuticals (NASDAQ: AMRX) agreed to acquire Kashiv BioSciences to create a fully integrated global biosimilars platform. The transaction combines Kashiv’s development and manufacturing with Amneal’s commercial scale, aims to accelerate the biosimilar pipeline, and is expected to close in the second half of 2026, subject to shareholder and regulatory approvals.
The combined company will target expanded patient access to affordable biologics and strengthened U.S. commercial positioning.
Amneal (Nasdaq: AMRX) agreed to acquire Kashiv BioSciences for $750 million upfront (cash and equity) plus up to $350 million in milestone payments, forming an integrated global biosimilars platform. The deal targets >$300B of biologics loss-of-exclusivity and is expected to close in H2 2026, subject to approvals.
Amneal reported preliminary Q1 2026 results: consolidated revenue $723M (+4%), gross margin 44.3% (+750 bps), net income $78M, and raised 2026 standalone guidance including adjusted EBITDA $740M–$770M.