Amneal Pharmaceuticals, Inc. - AMRX STOCK NEWS

Amneal Pharmaceuticals (AMRX) announced two major developments: the resubmission of its NDA for a DHE autoinjector for migraine and cluster headache treatment, and FDA approval of exenatide, its first generic injectable GLP-1 agonist. The DHE autoinjector would be the first and only of its kind, offering at-home self-administration without refrigeration or assembly. The FDA review is expected by Q2 2025. The exenatide approval (1.2 mL and 2.4 mL prefilled pens) demonstrates Amneal's capabilities in complex pharmaceuticals and peptide development, targeting type 2 diabetes treatment.

Amneal Pharmaceuticals (AMRX) reported Q3 2024 financial results with net revenue of $702 million, up 13% year-over-year. The company posted a GAAP net loss of $0.2 million and adjusted EBITDA of $158 million. Generics revenue increased 9%, Specialty revenue grew 19%, and AvKARE revenue rose 21%. Key developments include the launch of CREXONT® for Parkinson's disease, collaboration with Metsera for obesity medicines, and in-licensing of a new biosimilar. The company affirmed its 2024 full-year guidance with projected net revenue of $2.70-2.80 billion and adjusted EBITDA of $610-630 million.

Amneal Pharmaceuticals (Nasdaq: AMRX) has received FDA approval for its New Drug Application (NDA) for Pyridostigmine Bromide Extended-Release (PB ER) Tablets USP 105 mg. This once-daily product is designed for pretreatment against soman nerve agent poisoning in adults, specifically for the U.S. Armed Services and allies. Developed using Amneal's GRANDE® drug delivery technology, it offers potential for improved compliance and steady 24-hour release, replacing the current thrice-daily dosing regimen.

The project was partially funded by the U.S. government under Agreement W911QY-21-9-0018. This marks Amneal's second NDA approval this year, following CREXONT for Parkinson's disease. The most common serious adverse reactions reported were breathing difficulties, dizziness, and loss of consciousness.

Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) has announced that it will release its third quarter 2024 financial results on Friday, November 8, 2024, before the market opens. The company will host a conference call and live webcast with the investment community at 8:30 a.m. Eastern Time on the same day.

Investors can access the financial results and live webcast through the Investor Relations section of Amneal's website at https://investors.amneal.com. To join the webcast, individuals can register using the provided link. For those who prefer to join via phone, the U.S. dial-in number is 1 (833) 470-1428, with international numbers available through a separate link. The access code for the call is 088741.

A replay of the conference call will be made available shortly after the event and will remain accessible for seven days.

Amneal Pharmaceuticals (AMRX) and Metsera have announced a strategic collaboration to develop and supply next-generation medicines for obesity and metabolic diseases. Key points include:

1. Amneal will construct new manufacturing facilities in India for peptide synthesis and sterile fill-finish, with a net cost of $150-200 million over 4-5 years.

2. Metsera is advancing a portfolio of therapies, including ultra-long acting injectable and oral nutrient stimulated hormone (NuSH) analogs.

3. Amneal will be Metsera's preferred supply partner for developed markets and gain commercialization rights in select emerging markets.

4. The collaboration aims to deliver weight loss medicines at scale, leveraging Amneal's manufacturing expertise and Metsera's innovative drug portfolio.

Amneal Pharmaceuticals (Nasdaq: AMRX) has launched CREXONT® (carbidopa and levodopa) extended-release capsules for Parkinson's disease treatment. CREXONT® is now available in U.S. pharmacies nationwide. The novel formulation combines immediate-release granules and extended-release pellets, providing longer duration of "Good On" time with less frequent dosing compared to immediate-release CD/LD.

Amneal is implementing a comprehensive education program and extensive services to support healthcare providers and patients. Eligible commercially insured patients may qualify for a $25 copay through the CREXONT Savings Program. The company will also offer patient assistance and prior authorization support.

Amneal will present CREXONT at the International Congress of Parkinson's Disease and Movement Disorders on Sept. 27 – Oct. 1, 2024, including a launch symposium and scientific presentations.

Amneal Pharmaceuticals (AMRX) and Shilpa Medicare have received FDA approval for BORUZU™, the first ready-to-use version of bortezomib for subcutaneous administration. This oncology treatment is used for multiple myeloma and mantle cell lymphoma. BORUZU reduces compounding preparation steps, offering a more efficient solution for clinicians. It's Amneal's fourth 505(b)(2) injectable approval in 2024. The product is expected to launch with a unique J-code in Q2 2025. BORUZU references the branded product Velcade®, but offers a ready-to-use formulation. According to IQVIA®, U.S. annual sales for bortezomib were approximately $96 million for the 12 months ended December 2023.

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.