Amneal Pharmaceuticals Inc Stock Price, News & Analysis

Amneal Pharmaceuticals has announced the FDA's acceptance of the New Drug Application for IPX203, a novel oral formulation aimed at treating Parkinson's disease. This extended-release treatment promises longer symptom control with fewer doses compared to immediate-release formulations. The FDA has set a PDUFA date of June 30, 2023 for review. The RISE-PD trial demonstrated that IPX203 provides significantly more 'Good On' time and less 'Off' time while being less frequently dosed. The trial included 506 patients across several countries, further supporting product efficacy.

Amneal Pharmaceuticals (AMRX) reported Q3 2022 net revenue of $546 million, a 3.2% increase from $529 million in Q3 2021. The company faced a net loss of $3 million, an improvement from a $4 million loss a year earlier. Adjusted EBITDA fell 5.1% to $126 million. Diluted loss per share was $(0.02) compared to $(0.03) the previous year, while adjusted diluted EPS stood at $0.14. The company is maintaining its full-year guidance, targeting net revenue of $2.15 billion - $2.25 billion.

Amneal Pharmaceuticals (NYSE: AMRX) has received FDA approval for leuprolide acetate injection, indicated for the palliative treatment of advanced prostatic cancer. The product is expected to contribute to the growth of Amneal's injectables business, which has plans to launch eight new injectables in 2022. According to IQVIA, the annual sales for this product were $81 million for the 12 months ending September 2022, presenting a promising market potential.

Amneal Pharmaceuticals (NYSE: AMRX) has appointed Reem Malki as Senior Vice President, Chief Quality Officer, and Maryll W. Toufanian as Senior Vice President, Regulatory Strategy and Policy. Malki brings over 30 years of experience from Alvotech and Mylan, focusing on quality operations in biosimilars. Toufanian, an FDA veteran, previously directed the Office of Generic Drug Policy. These leadership appointments aim to enhance Amneal's capabilities in biosimilars, complex generics, injectables, and specialty areas, signaling a strategic expansion in high-growth sectors.

Amneal Pharmaceuticals, Inc. (NYSE: AMRX) will release its third quarter 2022 financial results on November 4, 2022, before market open. A conference call and live webcast for investors will follow at 8:30 a.m. Eastern Time. Access to the financial results and the live webcast is available on the Investor Relations section of the website. Callers can join by dialing 1 (844) 200-6205 or 1 (929) 526-1599 for international access, using access code 585341.

A replay will be available shortly after the call.

Amneal Pharmaceuticals (NYSE: AMRX) has launched ALYMSYS® (bevacizumab-maly), a new oncology biosimilar referencing Avastin®. This marks Amneal's entry into the rapidly growing $28 billion U.S. biosimilars market. ALYMSYS® aims to enhance access to affordable oncology treatments, especially given that the annual sales for bevacizumab reached $2.4 billion as of July 2022. The company plans to expand its biosimilars portfolio in the future, aligning with its mission for affordable medicines.

Amneal Pharmaceuticals, Inc. (NYSE: AMRX) announced the appointment of Gustavo Pesquin as Executive Vice President, Chief Commercial Officer - Specialty, effective September 6, 2022. Pesquin joins from Sanofi, bringing over 11 years of leadership experience, including roles as North America Head for General Medicines. His expertise is expected to enhance Amneal's growth in the Specialty segment, which focuses on central nervous system and endocrine disorders. The Co-CEOs expressed confidence that his diverse background will drive the company’s next phase of growth.

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.