Amneal Pharmaceuticals Inc Stock Price, News & Analysis

Amneal Pharmaceuticals (NYSE: AMRX) announced its participation in the Morgan Stanley Global Healthcare Conference on September 15, 2021, at 1:15 PM ET. Investors can access the live webcast through the company's Investor Relations page, with a replay available for 90 days afterward. Amneal is a fully-integrated pharmaceutical company based in Bridgewater, NJ, focusing on generic and specialty drug products, with a portfolio of approximately 250 product families.

Amneal Pharmaceuticals (NYSE: AMRX) announced positive topline results from its pivotal Phase 3 RISE-PD clinical trial for IPX-203, a novel formulation for Parkinson’s disease. The trial met its primary endpoint, showing an increase of 0.53 hours in “Good On” time compared to immediate-release CD/LD (p=0.0194). A New Drug Application submission to the FDA is planned for mid-2022. The trial involved 506 patients across 108 sites, demonstrating the drug's efficacy and safety, with 29.7% of patients reporting significant improvements (p=0.0015).

Amneal Pharmaceuticals (NYSE: AMRX) will host a virtual investment event on August 25, 2021, at 4:30 p.m. ET. The event will include presentations from management and medical experts. Key focus will be on IPX-203, an investigational oral formulation of extended-release CD/LD for Parkinson's patients, designed to improve absorption. Unlike RYTARY, IPX-203 uses innovative mucoadhesive polymers for rapid absorption. Amneal aims to enhance its portfolio with complex dosage forms and marketed brands, primarily in the CNS and endocrine disorders.

Amneal Pharmaceuticals, Inc. (NYSE: AMRX) reported strong second quarter results for 2021, achieving net revenues of $535 million, a 15% increase from $465 million in Q2 2020. The growth was attributed to successful Generic product launches and an uptick in Specialty products like Rytary® and Unithroid®. Notably, net income rose to $15 million, compared to a net loss of $12 million the previous year, driven by improved gross margins in Generics. Adjusted EBITDA also surged by 50% to $151 million. The company maintains its 2021 outlook for revenue between $2.1 and $2.2 billion.

Amneal Pharmaceuticals (NYSE: AMRX) has received FDA approval for its generic version of TobraDex®, Dexamethasone and Tobramycin Ophthalmic Suspension 0.3%/0.1%. This addition strengthens its generics portfolio, focusing on complex ophthalmic products. TobraDex® is used for steroid-responsive inflammatory ocular conditions and had U.S. sales of approximately $118 million for the year ending May 2021. The approval underscores Amneal's strategy to develop complex generics, enhancing its market position.

Amneal Pharmaceuticals, Inc. (NYSE: AMRX) will report its second quarter 2021 financial results on August 9, 2021, prior to market open. A conference call and live webcast for investors will take place at 8:00 a.m. Eastern Time on the same day, accessible via the company's Investor Relations webpage. Callers can join by dialing (844) 746-0741 in the U.S. or (412) 317-5273 internationally. A replay will be available for seven days using access code 10158095.

Amneal focuses on generics and specialty drug development, with a portfolio of about 250 product families.

Amneal Pharmaceuticals (NYSE: AMRX) announced the FDA's acceptance of its Biologics License Application (BLA) for Bevacizumab, a biosimilar to Avastin, with a standard review goal date in Q2 2022. Developed with mAbxience, Bevacizumab targets metastatic colorectal cancer and had U.S. sales of approximately $2.8 billion in the past year. The biosimilar Alymsys has already been approved in Europe. This milestone supports Amneal's strategy to enhance its biosimilar portfolio, which includes other products like Filgrastim and Pegfilgrastim.

Amneal Pharmaceuticals (NYSE: AMRX) announced that the FDA accepted its 505(b)(2) New Drug Application for a dihydroergotamine (DHE) prefilled syringe autoinjector. A decision is expected by mid-2022, with a potential launch in the second half of 2022. This product aims to provide patients with an easy-to-use self-administration method for acute migraine and cluster headaches. DHE's current U.S. sales are around $70 million annually, indicating a significant market opportunity. Amneal's strategy includes leveraging its existing commercial infrastructure in neurology.

Amneal Pharmaceuticals (NYSE: AMRX) announced its participation in two investor conferences. The RBC Global Healthcare Conference will be held on May 18, 2021, featuring a fireside chat at 1:55 p.m. ET. The Goldman Sachs 42nd Annual Global Healthcare Conference is scheduled for June 10, 2021, with a fireside chat at 3:50 p.m. ET. Both events will be accessible via live webcast on the Company's Investor Relations webpage. Amneal focuses on the development and distribution of generics and specialty products and holds a 65% stake in AvKARE.