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 (AMRX) generates news primarily through FDA regulatory decisions, product launch announcements, and financial performance disclosures. As a pharmaceutical company focused on generics and biosimilars, Amneal's news flow centers on drug approval milestones that directly impact its product portfolio and revenue potential.
The company announces FDA approvals for generic medications and biosimilar candidates, which represent the culmination of multi-year development programs and regulatory review processes. These approvals determine when Amneal can commercialize new products and enter markets previously dominated by brand-name drugs. Product launch announcements reveal the company's commercial strategy and competitive positioning within specific therapeutic categories.
Earnings reports provide visibility into Amneal's financial performance across its generics and specialty segments, though these documents often include forward-looking statements and time-sensitive metrics. The company also discloses material events through regulatory filings when significant business developments occur, such as manufacturing facility inspections, patent litigation outcomes, or strategic partnerships.
For pharmaceutical investors, Amneal's news coverage offers insights into the company's pipeline progression, regulatory success rates, and ability to navigate the complex approval process for generic and biosimilar products. The FDA approval announcements are particularly significant as they determine the timing and exclusivity status of new product launches in the competitive pharmaceutical market.
KeifeRx announced a research collaboration and option agreement with Amneal Pharmaceuticals (AMRX) to support pre-IND development of KFRX06, a brain-penetrant LRRK2 inhibitor candidate for Parkinson’s disease. KeifeRx will run a research program to generate key pre-IND outputs to help Amneal evaluate KFRX06 and inform potential next-stage development and commercialization. Financial terms were not disclosed. The agreement frames a structured path for possible future development, leveraging Amneal’s Parkinson’s disease franchise and development, manufacturing, and commercialization capabilities.
Amneal (NASDAQ: AMRX) announced FDA approval of two denosumab biosimilars: Boncresa (denosumab-mobz) referencing Prolia and Oziltus (denosumab-mobz) referencing XGEVA, dated Dec 22, 2025.
Under the Amneal–mAbxience partnership, mAbxience handles development and manufacturing while Amneal holds exclusive U.S. commercialization rights. The company expects to commercialize six biosimilars across eight presentations by 2027. IQVIA reports combined U.S. annual sales for Prolia and XGEVA of approximately $5.3 billion for the 12 months ended Oct 2025.
Amneal (Nasdaq: AMRX) announced U.S. FDA approval of epinephrine injection USP 1 mg/mL in both single-dose (1 mL) and multi-dose (30 mL) vials for hospitals and acute care settings, dated Dec 9, 2025. The approval expands Amneal’s institutional injectables portfolio and targets emergency and perioperative use including treatment of anaphylaxis and septic-shock–related hypotension.
The release notes common adverse reactions and references prescribing information; IQVIA U.S. annual sales for single- and multi-dose epinephrine vials were ~$118 million for the 12 months ended October 2025.
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.
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