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) reported positive interim Phase 4 ELEVATE-PD results for CREXONT (carbidopa/levodopa extended-release) from the first 55 patients after six weeks.
Key metrics: Good On time increased +3.13 hours (from IR CD/LD), +2.31 hours (IR CD/LD+COMT), +1.80 hours (Rytary); Off time reduced −2.83, −2.36, and −2.57 hours respectively; MDS-UPDRS total score improved −14.2, −4.1, and −13.9 points respectively. Good On time per dose also rose across cohorts.
Safety: TEAEs were generally mild-to-moderate; common events ≥3%: nausea 5.5%, falls 3.6%, dizziness 3.6%, UTI 3.6%. Longer-term and patient-reported outcomes will be presented in 2026.
Amneal (Nasdaq: AMRX) announced executives will participate in two investor conferences and that presentations will be webcast. Chirag Patel, Co‑Chief Executive and President, and Tasos Konidaris, Chief Financial Officer, will join the Piper Sandler 2025 Healthcare Conference for a fireside chat on December 3, 2025 at 9:30 AM EST in New York. They will also present at the J.P. Morgan 2026 Healthcare Conference on January 13, 2026 at 4:30 PM PST in San Francisco. A webcast and limited-time replays will be available on Amneal's Investor Relations site.
Amneal (Nasdaq: AMRX) announced U.S. FDA approval of its albuterol sulfate inhalation aerosol (90 mcg/actuation), the generic equivalent of PROAIR HFA, on December 2, 2025. This approval follows Amneal's recent FDA approval of a beclomethasone dipropionate inhalation aerosol (generic QVAR) and represents the company's second complex respiratory therapeutic approval in Q4 2025.
The company highlighted its respiratory manufacturing platform and positioned these approvals as advancing a differentiated, high‑value respiratory portfolio. IQVIA U.S. annual sales for albuterol sulfate inhalation aerosol were reported at approximately $1.5 billion for the 12 months ended September 2025.
Amneal (NASDAQ: AMRX) announced U.S. FDA approval of its cyclosporine ophthalmic emulsion 0.05%, a sterile, preservative-free formulation supplied in single-use vials and approved as the generic equivalent of RESTASIS.
The company says the product will launch in Q1 2026. The approval highlights Amneal’s sterile manufacturing capabilities and expansion in complex ophthalmic therapies. IQVIA U.S. annual sales for this product format were ~$2.0 billion for the 12 months ended September 2025. The drug is indicated to increase tear production for dry eye due to ocular inflammation; the most common adverse reaction was ocular burning.
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.