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 leading global pharmaceutical company headquartered in Bridgewater, NJ. Amneal develops, manufactures, and distributes a diverse portfolio of over 280 generic and specialty pharmaceutical products across the United States, India, and Ireland. With a commitment to providing affordable medicines, Amneal operates through three key segments: Generics, Specialty, and AvKARE.
Generics Segment: This segment focuses on producing a wide range of dosage forms and delivery systems, including injectables and biosimilars, contributing significantly to the company's revenue. The Generics segment is dedicated to expanding across complex product categories and therapeutic areas, ensuring patients have access to vital medications.
Specialty Segment: Amneal's Specialty segment promotes proprietary branded pharmaceuticals targeting central nervous system and endocrine disorders. The segment has a growing portfolio of branded pharmaceuticals with a pipeline focused on addressing unmet medical needs, demonstrating the company's commitment to innovation.
AvKARE Segment: This segment distributes pharmaceuticals and medical products to governmental agencies, specializing in re-packaging and wholesale distribution. AvKARE focuses on offering consistent care and pricing to qualified entities, enhancing access to essential medicines for governmental and institutional markets.
Recently, Amneal has achieved significant milestones, including the resubmission of a Complete Response to the FDA for IPX203, an oral formulation for Parkinson’s disease, and entering a licensing agreement with Zambon Biotech for IPX203 in Europe. The company also launched PEMRYDI RTU®, the first ready-to-use version of pemetrexed for injection, underscoring their commitment to oncology treatment advancements.
Amneal's financial performance remains robust, with net revenue of $2.39 billion in 2023 and a strategic focus on expanding its reach through innovative products and international partnerships. The company continuously invests in research and development to meet the growing demands for affordable and high-quality medications, solidifying its position as a key player in the pharmaceutical industry. For more information, please visit www.amneal.com.
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.
Amneal Pharmaceuticals (Nasdaq: AMRX) has started supplying its over-the-counter (OTC) Naloxone Hydrochloride (Naloxone HCI) Nasal Spray, 4mg, to U.S. retail pharmacies and the State of California. Approved by the FDA in April 2024, this generic equivalent to OTC NARCAN® HCI Nasal Spray is now available for direct distribution nationwide. The company has a distribution agreement with California under the CalRx® Naloxone Access Initiative and aims to produce approximately ten million two-packs annually at its New Jersey facility starting in 2025. Amneal is also engaging with other states and municipalities to expand access to this life-saving medication amid the ongoing opioid epidemic.
Amneal Pharmaceuticals (Nasdaq: AMRX) announced that its Co-CEO, Chirag Patel, and CFO, Tasos Konidaris, will participate in the 2024 Jefferies Healthcare Conference on June 5, 2024. Chirag Patel is scheduled to present at 1:30 PM EST. A live webcast of the presentation will be available on the company's website, with a replay accessible after the event.
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