Medincell: FDA Accepts Injectable Olanzapine Application
Teva Pharmaceuticals and Medincell announce that the U.S. Food and Drug Administration has accepted the marketing authorization application for olanzapine LAI, a long-acting subcutaneous injection intended for the treatment of schizophrenia in adults. This monthly treatment represents a novel therapeutic approach in the portfolio of long-acting injectable drugs of both companies.
Olanzapine LAI (TEV-749) is designed as a monthly subcutaneous injection using Medincell's SteadyTeq technology. This treatment aims to improve therapeutic adherence and clinical stability in patients with schizophrenia. According to data from the phase 3 SOLARIS trial, olanzapine LAI demonstrated an efficacy and tolerance profile comparable to currently available olanzapine formulations. The study particularly evaluated the absence of the need for post-injection monitoring, unlike existing formulations which require three-hour monitoring in a certified health facility.
FDA Review Process Underway
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The FDA's acceptance of the application initiates a standard review period of about eight months. Teva continues the development of this therapeutic option as part of its Pivot to Growth strategy, solidifying its scientific positioning in complex neurological disorders. Medincell is thus strengthening its portfolio of drug candidates at various stages of development in the field of long-acting injectable treatments. Olanzapine LAI remains experimental and has not been approved by any regulatory authority.
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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