Teva Pharmaceutical Industries Limited American Depositary Shares - TEVA STOCK NEWS

Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) has received a complete response letter (CRL) from the U.S. FDA regarding its partner Alvotech's (NASDAQ: ALVO) Biologics License Application for AVT02, a biosimilar to Humira (adalimumab). The FDA's CRL indicates that the application cannot be approved due to deficiencies identified at Alvotech's manufacturing facility, which need resolution. Despite this setback, Teva reaffirms its commitment to leadership in the biosimilars market and expresses optimism about its product pipeline, including further advancements with AVT02.

Teva Pharmaceuticals announced the FDA approval of AUSTEDO XR (deutetrabenazine) once-daily extended-release tablets on February 17, 2023. AUSTEDO XR is therapeutically equivalent to the existing twice-daily AUSTEDO tablets for adults with tardive dyskinesia (TD) and chorea associated with Huntington’s disease (HD). This new formulation is expected to be available commercially later this year. Teva will present data supporting AUSTEDO XR's approval at the American Academy of Neurology (AAN) Annual Meeting on April 22-27, 2023, demonstrating bioequivalence and safety across various dose strengths (6 mg, 12 mg, and 24 mg). Teva's research highlights the improved therapeutic options for patients living with TD and HD chorea.

Teva Pharmaceutical Industries (NYSE: TEVA) has partnered with Rimidi to implement a respiratory patient monitoring program at Desert Oasis Healthcare in California. Utilizing data from Teva's Digihaler System, the program aims to enhance asthma management and reduce costs and hospitalizations. Digihaler is recognized as the only smart inhaler providing objective data to aid in treatment planning. Teva and Rimidi plan to expand this initiative to other health systems, emphasizing their commitment to integrating technology in healthcare to improve patient outcomes and predictive capabilities in asthma management.

Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) announced early tender results for its tender offers related to several series of its senior notes. The company is increasing the tender caps for its Pool 1 Notes to $1.65 billion, Pool 2 Notes to $450 million, and Pool 3 Notes to approximately $293.3 million, while the Pool 4 Notes cap remains at $250 million. The total maximum amount for the offers is $2.5 billion. Teva aims to manage and extend its debt maturity profile and plans to fund these offers through proceeds from a recent public offering and cash reserves. Settlement is expected on March 15, 2023, and the offers will expire on March 27, 2023.

Teva Pharmaceuticals, in collaboration with NATCO Pharma, has launched additional strengths of its generic lenalidomide capsules in the U.S., including 2.5 mg and 20 mg doses. This follows the introduction of four other strengths in March 2022, making all formulations of lenalidomide available in the U.S. The generic is critical for treating multiple myeloma, myelodysplastic syndromes, and mantle cell lymphoma. With nearly 500 generic products, Teva leads the market and holds around 100 pending first-to-file opportunities. Lenalidomide's annual sales reached $2.9 billion as of January 2023, enhancing Teva's position in the generics market.

Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) will have its Chief Financial Officer, Eli Kalif, present at the Barclays Global Healthcare Conference on March 14, 2023, at 10:15 A.M. Eastern Time. Investors can access a live webcast of the presentation via Teva's Investor Relations website. A recorded version will be available within 24 hours and can be accessed for up to 90 days. Teva is recognized for its extensive portfolio of over 3,500 products and plays a crucial role in global healthcare, serving approximately 200 million patients daily.

Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) has initiated tender offers with a maximum purchase price of $2.25 billion to buy back various series of senior notes. The notes include 7.125%, 6.000%, and 4.500% Senior Notes, among others. The offers aim to manage and extend Teva's debt maturity profile and will be funded through a financing transaction expected to raise at least $2.0 billion. The offers are set to expire on March 27, 2023, with an early tender deadline of March 10, 2023. Holders of validly tendered notes will receive accrued interest plus specified consideration.