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) 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.
Amneal (Nasdaq: AMRX) announced positive interim Phase 4 ELEVATE-PD results (first 111 patients, six weeks) showing clinically meaningful benefits after switching to CREXONT. Patients switching from RYTARY gained +3.07 hours daily “Good On” time and nearly doubled continuous “Good On” intervals to 6.58 hours.
Across prior therapies CREXONT increased “Good On” time, reduced “Off” time, and improved MDS-UPDRS scores; common adverse events included dizziness and nausea.
Amneal (Nasdaq: AMRX) launched two metered-dose inhalation (MDI) generics in the U.S. on April 14, 2026: albuterol sulfate inhalation aerosol (90 mcg) and beclomethasone dipropionate HFA inhalation aerosol (40/80 mcg), both FDA-approved in 2025.
These are Amneal’s first U.S. MDI launches, manufactured at its dedicated inhalation facility in Ireland. According to IQVIA U.S. annual sales data, 12-month sales through Feb 2026 were about $1.5B for albuterol and $321M for beclomethasone, indicating meaningful market opportunity.
Amneal (NASDAQ:AMRX) launched bimatoprost ophthalmic solution 0.01% on April 9, 2026 in 2.5 mL, 5 mL and 7.5 mL sizes. The product is the generic equivalent of LUMIGAN and is indicated to reduce elevated intraocular pressure in open-angle glaucoma or ocular hypertension.
Amneal said the launch supports its Affordable Medicines segment and cites IQVIA U.S. annual sales of approximately $719 million for the 12 months ended February 2026.
Amneal (NASDAQ: AMRX) will release its first quarter 2026 financial results on Friday, May 1, 2026 before market open. The company will host a live audio webcast at 8:30 a.m. ET, accessible via the Investor Relations site, with a conference line and replay posted after the call.
Dial-in details and the access code 458312872 are provided for conference access; registration is available on the Investor Relations website.
Amneal (Nasdaq: AMRX) announced a $2 million donation to multiple patient assistance foundations to support people living with Parkinson’s disease during Parkinson’s Awareness Month (April 2026).
The funds will help eligible patients cover out-of-pocket costs for FDA-approved Parkinson’s medications; Amneal said it has donated $3.5 million to Parkinson’s causes over the past two years and will continue advocacy, education, and Spanish-language resources.