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 (Nasdaq: AMRX) announced U.S. FDA approval of its iohexol injection (300 mg Iodine/mL), the first generic version of GE HealthCare's Omnipaque, with an expected commercial launch in Q1 2026. The product is indicated for intrathecal, intra-arterial, intravenous, oral, rectal, intraarticular and body cavity imaging in adults and pediatric patients two weeks and older. IQVIA U.S. annual sales for iohexol injection were approximately $652 million for the 12 months ended September 2025. Important safety information includes a Boxed Warning about serious adverse reactions associated with intrathecal administration at a wrong iodine concentration.
Amneal (NASDAQ: AMRX) reported Q3 2025 net revenue of $785 million (up 12% vs. Q3 2024) and GAAP net income of $2 million; diluted GAAP EPS was $0.01. Adjusted EBITDA was $160 million (up 1% year-over-year) and adjusted diluted EPS was $0.17 (up 6% year-over-year).
Specialty and Affordable Medicines each rose ~8%; AvKARE revenue grew 24%. The company updated 2025 guidance: net revenue $3.0B–$3.1B, adjusted EBITDA $675M–$685M, adjusted diluted EPS $0.75–$0.80, and operating cash flow $300M–$330M. Management cited branded launches (CREXONT, BREKIYA) and a product launch cycle plus a recent refinancing as drivers of momentum.
Amneal (NYSE:AMRX) announced on October 29, 2025 that the U.S. Food and Drug Administration has provided tentative approval for its ANDA for beclomethasone dipropionate HFA inhalation aerosol in 40 mcg and 80 mcg strengths.
The product is the generic equivalent of QVAR and is indicated as maintenance prophylactic therapy for asthma in patients five years and older (not for acute bronchospasm). This is Amneal’s first metered‑dose inhaler (MDI), marking an expansion into complex respiratory therapies. IQVIA U.S. annual sales for the branded product were approximately $329 million for the 12 months ended August 2025.
Amneal (Nasdaq: AMRX) launched Brekiya® (dihydroergotamine mesylate) autoinjector on October 27, 2025, the first ready-to-use DHE autoinjector approved in the U.S. for acute treatment of migraine with or without aura and acute cluster headaches in adults.
Brekiya is available by prescription exclusively through Walgreens Specialty Pharmacy and Sterling Specialty Pharmacy. Eligible commercially insured patients may pay as little as $40 per carton (4 single-dose autoinjectors). Important boxed warning: do not coadminister with strong CYP3A4 inhibitors due to rare reports of peripheral ischemia.
Kashiv Biosciences (NASDAQ:ALVO) submitted a BLA to the U.S. FDA and had its MAA accepted by the EMA for ADL-018, a proposed biosimilar to XOLAIR® (omalizumab).
The company highlights ADL-018’s potential to be among the first-wave omalizumab biosimilars addressing a large market: ~$5.5B global, ~$4.1B U.S., and ~$1.0B E.U. annual sales (IQVIA, 12 months ending June 2025). Kashiv partners with Alvotech (AVT23) and cites Amneal’s commercial expectations for multiple biosimilar launches from 2026–2027.
Amneal Pharmaceuticals (NASDAQ: AMRX), a global biopharmaceutical company, has scheduled its third quarter 2025 financial results announcement for Thursday, October 30, 2025, before market open.
The company will host an audio webcast at 8:30 a.m. ET accessible through their Investor Relations website. Participants can join via webcast or dial in using 1 (833) 470-1428 in the U.S. with access code 272787. International toll-free numbers are available, and a replay will be provided after the call.
Amneal Pharmaceuticals (Nasdaq: AMRX) has submitted a Biologics License Application (BLA) to the FDA for a proposed biosimilar to XOLAIR® (omalizumab), developed by Kashiv BioSciences. The submission came earlier than expected for this therapeutic targeting the $4.1 billion U.S. market.
The biosimilar aims to treat moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps, food allergies, and chronic spontaneous urticaria. This represents Amneal's potential first-wave entry into the omalizumab market, adding to their portfolio of three marketed biosimilars, with five more launches planned for 2026-2027.
Due to the early submission, Amneal will incur a $22.5 million R&D milestone charge in Q3 2025 instead of Q4, which was already included in their financial guidance.
Amneal Pharmaceuticals (NYSE:AMRX) has received FDA approval for its generic version of bimatoprost ophthalmic solution 0.01%, equivalent to LUMIGAN®. The treatment, indicated for reducing elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension, represents a significant addition to Amneal's Affordable Medicines portfolio.
The approval covers multiple sizes (2.5 mL, 5 mL and 7.5 mL) of the solution. According to IQVIA® data, the reference product generated approximately $685 million in U.S. annual sales for the 12 months ended July 2025, highlighting substantial market opportunity for Amneal.
Amneal Pharmaceuticals (NYSE:AMRX) has received FDA approval for its sodium oxybate oral solution 500 mg/mL ANDA, referencing Jazz Pharmaceuticals' Xyrem®. The drug is approved for treating cataplexy or excessive daytime sleepiness in narcolepsy patients aged 7 and older.
This approval expands Amneal's Affordable Medicines portfolio, offering a more cost-effective alternative in a market previously dominated by a single manufacturer. The drug addresses a rare neurological condition affecting approximately 150,000 individuals in the United States. Amneal had previously distributed an authorized generic version in limited quantities.
Amneal Pharmaceuticals (NYSE:AMRX) has received FDA approval for risperidone extended-release injectable suspension in multiple dosage strengths (12.5 mg, 25 mg, 37.5 mg, and 50 mg/vial), a generic version of Janssen's Risperdal Consta®. The product, which received Competitive Generic Therapy (CGT) designation with 180-day exclusivity, will be launched in Q4 2025.
The injectable suspension, designed for treating schizophrenia and Bipolar I disorder, demonstrates Amneal's expertise in complex pharmaceuticals, particularly in microsphere formulation and cold-chain manufacturing. The reference product generated approximately $194 million in U.S. annual sales for the 12 months ended July 2025, according to IQVIA®.