Medincell receives FDA approval for WELTRUZA™ (olanzapine)

MONTPELLIER, France--()--October 09, 2026-- Medincell (Paris:MEDCL) Medincell will host Investor webcast today to discuss the implications of the approval for the Company and answer questions from analysts. Webcast Details Date: Friday, October 9, 2026 Time: 4:00 p.m. CEST / 10:00 a.m. ET Webcast: A replay of the webcast will be available on Medincell's website following the event. ------------------------------------------------------------------------------ Medincell (Euronext: MEDCL) achieves major milestone with the announcement by its partner Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd, of the U.S. Food and Drug Administration (FDA) approval of WELTRUZA(TM) (olanzapine) for extended-release injectable suspension, as the first and only once-monthly subcutaneouslong-acting injectable (LAI) formulation of olanzapine for adults with schizophrenia that can help support stabilization for people living with schizophrenia. WELTRUZA(TM) does not require loading doses or oral supplementation at treatment initiation and eliminates the need for post-injection monitoring, addressing a major, long-standing gap in schizophrenia care. The approval of WELTRUZA(TM) marks the second FDA-approved medicine utilizing Medincell's long-acting injectable technology, following UZEDY(R) (risperidone) in 2023. Teva Pharmaceuticals plans to make WELTRUZA(TM) available in the United States in the coming weeks. Medincell is entitled to mid- to high-single digit royalties on worldwide net sales of WELTRUZA(TM). Medincell is also eligible to receive up to $112 million in development and commercial milestones, including a $4 million payment upon U.S. approval and up to $105 million in sales-based commercial milestones upon achievement of specified sales thresholds. Christophe Douat, CEO of Medincell, said: "Beyond its clinical significance, the FDA approval of WELTRUZA(TM) represents a major milestone in the execution of Medincell's Shift to Growth strategy, with the emergence of a second significant growth engine for the Company. This approval provides further validation of our technology and demonstrates our ability to transform innovation into differentiated medicines that create long-term value for patients, partners and shareholders." For additional information regarding WELTRUZA(TM), please refer to Teva Pharmaceuticals' press release: About Medincell medincell.com View source version on.com: CONTACT: David Heuzé Head of Corporate and Financial Communications, and ESG david.heuze@Medincell.com / +33 (0)6 83 25 21 86 Grace Kim Chief Strategy Officer, U.S. Finance grace.kim@medincell.com / +1 (646) 991-4023 (END) Dow Jones Newswires October 09, 2026 08:14 ET (12:14 GMT) The statements in this document shall not be considered as an objective or independent explanation of the matters. Please note that this document (a) has not been prepared in accordance with legal requirements designed to promote the independence of in