EMA accepts Teva, Medincell schizophrenia drug MAA
Analysis based on 9 articles · First reported May 21, 2026 · Last updated May 21, 2026
The acceptance of the Marketing Authorization Application for TEV-'749 by the European Union — European Medicines Agency is a positive development for Sun Pharma Ltd. and Medincell. This could lead to the approval and commercialization of a new treatment for Schizophrenia in Europe, potentially boosting the stock prices of both companies and opening a new market for their product.
The European Union — European Medicines Agency has accepted the Marketing Authorization Application (MAA) for olanzapine long-acting injectable (TEV-'749), a drug developed by Sun Pharma Ltd. and Medincell for the treatment of Schizophrenia in adults. This drug, utilizing Medincell's SteadyTeq technology, aims to improve treatment adherence and long-term disease management for patients. The submission is supported by the Phase 3 SOLARIS study, which demonstrated efficacy and a safety profile consistent with oral olanzapine. If approved, TEV-'749 could address a significant unmet need in schizophrenia treatment options in Europe.
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