Amneal Pharmaceuticals Inc Stock Price, News & Analysis

Amneal Pharmaceuticals has submitted a New Drug Application (NDA) to the FDA for IPX203, an extended-release formulation of carbidopa/levodopa aimed at improving treatment for Parkinson's disease. Results from the Phase 3 RISE-PD trial showed IPX203 provided an average of 1.55 more hours of 'Good On' time compared to immediate-release formulations, despite being taken less frequently. The formulation aims to address the needs of Parkinson's patients for enhanced motor control and less frequent dosing.

Amneal Pharmaceuticals (NYSE: AMRX) announced its support for the newly formed Congressional Domestic Pharmaceutical Manufacturing Caucus, aimed at ensuring a resilient supply chain of essential medicines manufactured in the U.S.. The caucus, led by a bipartisan group of representatives, seeks to address supply chain vulnerabilities highlighted by the pandemic and geopolitical conflicts. Co-CEOs Chirag and Chintu Patel emphasized the importance of domestic manufacturing for national security and aim for legislative solutions to drive change in pharmaceutical supply chains.

Amneal Pharmaceuticals (NYSE: AMRX) has received FDA approval for four generic products, expanding its essential medicines portfolio. The approved products include vasopressin injection, famotidine for oral suspension, atropine sulfate ophthalmic solution, and clindamycin phosphate topical gel. Together, these products represent a market potential of approximately $784 million. Amneal aims to launch 20-30 generics annually, with this latest approval bringing their year-to-date launches to 16. This strategic move is expected to enhance their position in the generics market.

Amneal Pharmaceuticals (AMRX) reported Q2 2022 net revenue of $559 million, up 5% from Q2 2021. However, the company faced a net loss of $121 million, primarily due to a $263 million charge for antitrust litigation. Adjusted EBITDA was $135 million, a decrease of 6%. Diluted loss per share stood at $(0.80), while adjusted diluted EPS was $0.19. The company revised its 2022 guidance, projecting net revenue of $2.15 billion to $2.25 billion and adjusted EBITDA of $500 million to $520 million.

Amneal Pharmaceuticals (NYSE: AMRX) appointed Deborah M. Autor as a new independent director on July 29, 2022. Autor brings extensive expertise in the biopharmaceutical industry, particularly in quality, regulatory affairs, and policy. Her background includes key roles at AstraZeneca and Mylan N.V., as well as significant experience with the FDA, where she served as Deputy Commissioner. The addition of Autor aims to strengthen Amneal's leadership as the company targets growth in complex pharmaceutical markets.

Amneal Pharmaceuticals, Inc. (NYSE: AMRX) will release its second quarter 2022 financial results on August 5, 2022, before market open. A conference call and live webcast will occur at 8:30 a.m. Eastern Time the same day, accessible via the Investor Relations section of Amneal's website. Interested parties can join the call by dialing 1 (844) 200-6205 (U.S.) or 1 (929) 526-1599 (international), using access code 236256. A replay will be available after the call. Amneal is a fully integrated essential medicines company, producing over 250 products.

Amneal Pharmaceuticals (NYSE: AMRX) has launched LYVISPAH, a new baclofen oral granule product approved by the FDA for spasticity associated with multiple sclerosis and spinal cord disorders. Available in 5mg, 10mg, and 20mg packets, LYVISPAH offers flexible dosing options, addressing difficulties some patients face when swallowing pills. This marks Amneal’s first specialty product launch since 2015 and aligns with its strategy to expand its specialty business. The U.S. market for baclofen generated $130 million in annual sales for the year ending March 2022.

Amneal Pharmaceuticals (NYSE: AMRX) recently announced FDA approval for FYLNETRA (pegfilgrastim-pbbk), a biosimilar to Neulasta®, marking its third biosimilar approval in 2022. Developed in partnership with Kashiv Biosciences, FYLNETRA is intended to treat neutropenia in chemotherapy patients. This approval further solidifies Amneal's position in the $28 billion U.S. biosimilars market, where annual pegfilgrastim sales reached $3.1 billion. The company plans to launch FYLNETRA along with its other biosimilars later this year.