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) 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®.
Amneal Pharmaceuticals (NASDAQ: AMRX) reported strong Q2 2025 financial results with net revenue of $725 million, up 3% year-over-year, and net income of $22 million. The company achieved notable growth with Adjusted EBITDA of $184 million, a 13% increase, and adjusted diluted EPS of $0.25, up 56% from Q2 2024.
Key highlights include a 23% increase in Specialty net revenue driven by products like CREXONT®, RYTARY®, and UNITHROID®. The company successfully completed a $2.7 billion debt refinancing, extending maturities to 2032 and reducing interest costs. Based on strong performance, Amneal raised its full year 2025 guidance, increasing adjusted EBITDA targets to $665-685 million and adjusted EPS to $0.70-0.75.
[ "Net revenue increased 3% to $725 million year-over-year", "Specialty segment revenue grew 23% driven by key branded products", "Adjusted EBITDA increased 13% to $184 million", "Adjusted diluted EPS grew 56% to $0.25", "Successfully completed $2.7B debt refinancing with extended maturities to 2032", "Raised full year 2025 guidance for adjusted EBITDA and EPS", "Operating cash flow guidance increased to $275-305 million" ]Amneal Pharmaceuticals (NASDAQ: AMRX) has announced a major refinancing initiative through its subsidiary, Amneal Pharmaceuticals LLC. The company plans to secure $1.8 billion in new seven-year term B loans and is offering $750 million in senior secured notes due 2032.
The proceeds will be used to refinance existing term B loans, repay a portion of outstanding ABL facility borrowings, and cover related expenses. The notes will be guaranteed on a senior secured basis and will have first-priority liens on collateral (except ABL priority collateral) and second-priority liens on ABL priority collateral. The completion of these transactions remains subject to market conditions.
The notes will be offered exclusively to qualified institutional buyers under Rule 144A and non-U.S. persons under Regulation S of the Securities Act.Amneal Pharmaceuticals (NASDAQ: AMRX) has released preliminary Q2 2025 financial results showing strong performance. The company reported net revenue of $720-730 million, up 3% year-over-year, and Adjusted EBITDA of $180-185 million, increasing approximately 13% from Q2 2024.
Key highlights include improved leverage metrics, with gross leverage decreasing to 3.8x from 4.1x and net leverage reducing to 3.7x from 3.9x. The quarter also marked the FDA approval of Brekiya® autoinjector for migraine treatment and strong uptake of CREXONT®. The company expects to meet or exceed its full-year 2025 guidance and plans to submit a BLA for a proposed XOLAIR® biosimilar in Q4 2025.
FAQ
What is the current stock price of Amneal Pharmaceuticals (AMRX)?
What is the market cap of Amneal Pharmaceuticals (AMRX)?
