Teva Pharmaceuticals Files Application with FDA for Olanzapine LAI
Teva Pharmaceuticals, in partnership with Medincell, has submitted an application to the FDA for the approval of Olanzapine LAI, intended for the treatment of schizophrenia in adults.
The submission of the market authorization application could influence future outlooks, but no specific figures are provided in the release. Medincell is focused on the development of long-acting injectable treatments for various therapeutic areas.
Details of the Submission
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Teva Pharmaceuticals' submission pertains to Olanzapine LAI, a long-acting olanzapine injection aimed at treating schizophrenia in adults. This product is designed to enhance treatment adherence and clinical stability of patients. The regulatory process initiated by the submission to the FDA includes an initial two-month period to accept the review, followed by an eight-month standard evaluation of the application.
Medincell's Development Strategy
Medincell is developing injectable treatments using BEPO technology, which allows for controlled drug release over extended periods. Their product risperidone LAI has already been approved for schizophrenia and bipolar I disorder. The company collaborates with pharmaceutical partners to offer new treatment options globally. The development of Olanzapine LAI is part of this strategy to meet significant therapeutic needs.
We are pleased with the company’s growth and momentum.
Total income €14,1 million; Revenues €11,6 million (+35 %); UZEDY® royalties €4,2 million; Operating result €(6,6) million (improved 13 % year-over-year); Net result €(16 078) thousand; Cash and low-risk financial investments €53,5 million (incl. €49,8 million cash and €3,7 million low-risk investments); Net financial debt €17 629 thousand; NDA for Olanzapine LAI submitted to FDA on December 9, 2025; AbbVie partnership advancing with regulatory package expected in 2026.
Risks mentioned
Foreign exchange risk: weakness of USD vs EUR impacted revenues and generated ~€1 million FX losses
Dependency on partner commercialization (Teva) for UZEDY® royalties and sales forecasts
Regulatory risk: approvals (e.g., Olanzapine LAI) and acceptance for review uncertain
Financial volatility linked to fair value revaluation of EIB BSA warrants (non-cash €6,8 million impact)
Opportunities identified
Olanzapine LAI: NDA submitted and potential launch could be a major growth catalyst
UZEDY®: upward revision of 2025 net sales forecast by Teva (from $160 million to $190-200 million)
AbbVie partnership: first program advancing toward first-in-human trials (regulatory package expected 2026)
Gates Foundation financing: new $3 million envelope to advance mdc-STM malaria program
Expanded geographic approvals (Canada, South Korea) supporting broader commercialization
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