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 Pharmaceuticals (Nasdaq: AMRX) has received FDA approval for Propofol Injectable Emulsion USP in single-dose vials. Propofol, an essential surgical anesthetic, is currently on the ASHP drug shortages list. Amneal plans to manufacture the product in-house on a dedicated line to ensure consistent supply, with a launch expected in Q4 2024.
The approval covers three dosage strengths: 200 mg/20 mL, 500 mg/50 mL, and 1,000 mg/100 mL. This complex emulsion injectable expands Amneal's portfolio and addresses supply chain constraints. According to IQVIA®, U.S. annual sales for propofol were approximately $314 million for the 12 months ended June 2024.
Amneal Pharmaceuticals (AMRX) reported strong Q2 2024 results, with net revenue of $702 million, up 17% year-over-year. The company achieved GAAP net income of $6 million and diluted income per share of $0.02. Adjusted EBITDA increased 11% to $162 million, while adjusted diluted EPS was $0.16. Generics revenue grew 14%, Specialty revenue increased 7%, and AvKARE revenue surged 33%.
Based on these results, Amneal has raised its full-year 2024 guidance. The company now expects net revenue between $2.70-$2.80 billion, adjusted EBITDA of $610-$630 million, and adjusted diluted EPS of $0.57-$0.63. The recent FDA approval of CREXONT® for Parkinson's disease is seen as a new long-term growth driver.
Amneal Pharmaceuticals (Nasdaq: AMRX) has received FDA approval for CREXONT® (carbidopa and levodopa extended-release capsules) to treat Parkinson's disease. This novel formulation combines immediate-release granules and extended-release pellets, providing more 'Good On' time with less frequent dosing compared to immediate-release CD/LD. Key benefits include:
1. 0.5 hours additional 'Good On' time per day
2. Average of 3 doses daily vs. 5 for IR CD/LD
3. 1.6 hours additional 'Good On' time per dose
4. Safety profile consistent with IR CD/LD
Amneal plans to launch CREXONT commercially in September 2024, targeting the approximately one million people with Parkinson's disease in the U.S.
Amneal Pharmaceuticals (Nasdaq: AMRX) has received FDA approval for its potassium phosphates in 0.9% sodium chloride injection intravenous (IV) ready-to-use bags. This is the first preservative-free presentation of potassium phosphates in a single-dose IV infusion bag. It's Amneal's third 505(b)(2) injectable launch in 2024, following PEMRYDI RTU® and FOCINVEZ®. The product is indicated to correct hypophosphatemia in adults and pediatric patients weighing 40 kg or more when oral or enteral replacement isn't possible. It's latex-free and can be stored at room temperature. Amneal plans to launch the product in Q3 2024, expanding its injectables portfolio with this differentiated offering for hospitals.
Amneal Pharmaceuticals (NASDAQ: AMRX) will release its second quarter 2024 financial results on August 9, 2024, before market open.
The company will host a conference call and live webcast at 8:30 a.m. Eastern Time to discuss the results.
Details for accessing the call and webcast are available on the company's Investor Relations website.
Participants need to register for the conference call to receive dial-in details and a unique PIN.
A replay of the call will be accessible for seven days following the event.
Amneal Pharmaceuticals (NASDAQ: AMRX) has launched FOCINVEZ™, the first ready-to-use version of fosaprepitant, an anti-nausea agent used in chemotherapy. Unlike other versions, FOCINVEZ does not require reconstitution or dilution, enhancing pharmacy efficiency. It's approved for adults and children over 6 months for preventing nausea and vomiting in highly and moderately emetogenic chemotherapy. The product has a unique CMS reimbursement code J1434 and reported U.S. sales of $36 million over the past year. Adverse effects include fatigue, diarrhea, and neutropenia. This is Amneal’s second ready-to-use injectable in 2024, marking growth in their injectables portfolio.
Amneal Pharmaceuticals has expanded its biosimilar portfolio to include omalizumab, a biosimilar referencing XOLAIR®. Omalizumab is used to treat chronic conditions like severe allergic asthma and chronic urticaria. Developed by Kashiv BioSciences, this biosimilar is currently in a Phase III clinical trial initiated in Q3 2023. With this addition, Amneal's biosimilar portfolio now includes eight products, covering a new therapeutic area beyond oncology. The U.S. annual sales for XOLAIR® reached approximately $3.2 billion as of April 2024. Financial terms were not disclosed, but the associated costs are accounted for in Amneal's guidance.
Kashiv BioSciences has entered into an exclusive licensing agreement with Amneal Pharmaceuticals for the U.S. commercialization of ADL018, a proposed biosimilar to XOLAIR® (omalizumab).
ADL018 is currently in Phase III clinical trials, which began in Q3 2023. Omalizumab, a monoclonal antibody targeting IgE, is used to treat conditions like severe allergic asthma and chronic rhinosinusitis with nasal polyps.
This collaboration builds on the successful U.S. biosimilar partnership between the two companies for oncology products RELEUKO® and FYLNETRA®.
Annual U.S. sales for XOLAIR® were approximately $3.2 billion as of April 2024. Financial terms of the agreement were not disclosed.
Amneal Pharmaceuticals (Nasdaq: AMRX) has released its fourth Environmental, Social, and Governance (ESG) Report for 2023. The report details the company's progress in environmental sustainability, human capital management, and corporate governance. Key achievements include the launch of 39 new generics and injectable products, entering the Indian market, participating in the Association of Accessible Medicines (AAM) and the Biosimilars Forum. The company has also conducted its first Materiality Assessment to identify ESG risks and opportunities. Amneal has implemented greenhouse gas accounting software and developed sustainability-focused inventory management plans. The company aims to improve gender diversity and has expanded its Employee Resource Group (ERG) program. Amneal emphasizes good governance with a robust Corporate Compliance Program.
Amneal Pharmaceuticals (Nasdaq: AMRX) announced the addition of six new injectable therapies in Q2 2024, expanding its US market portfolio to over 40 products. This move aims to address chronic shortages of critical injectables, especially in oncology. Notably, three of these new products are listed on the American Society of Health System Pharmacists (ASHP) drug shortage list, increasing Amneal's total ASHP-listed injectables to 13. The new products include PEMRYDI RTU® (vial), Atropine sulfate (pre-filled syringe), Docetaxel (injection), Foscarnet (IV bag), Methylprednisolone acetate (multi-dose vial), and Calcium gluconate (vial). The company has tripled its production capacity to 60 million units across four facilities and aims to introduce 60 injectables by 2025, including branded oncology products to enhance pharmacy efficiency.