MedInCell Stock: Surge Driven by FDA's Acceptance of Olanzapine Filing
MedInCell stock is up 2.6% this Monday morning at 24.50 euros, following a major regulatory announcement in the United States. The Montpellier-based company benefits from the FDA's acceptance of its application for authorization for its injectable olanzapine treatment, developed in partnership with Teva Pharmaceuticals.
FDA Accepts MedInCell's Injectable Olanzapine for Review
MedInCell's stock rebounded after the release on Friday, February 20, of a statement confirming that the U.S. health agency has accepted the marketing authorization application for a monthly subcutaneous injectable formulation of olanzapine, intended for the treatment of schizophrenia in adults. This product, developed jointly with Teva Pharmaceuticals, is based on the French biotech's proprietary extended-release technology. The FDA's acceptance of this dossier marks a key milestone in the regulatory process and opens up prospects for commercialization in the world's leading drug market. Regarding the financial calendar, the company's upcoming milestones include the publication of the annual results for the fiscal year 2025-2026, scheduled for June 16, 2026, followed by the general meeting planned for September 10. These events will provide insights into the operational trajectory and revenues from ongoing partnerships.
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Despite today's rise, MedInCell's stock price is still below its 50-day moving average at 25.49 euros, a level that acts as an intermediate resistance. A sustained crossing of this threshold would be a short-term bullish reversal signal. However, the stock remains well above its 200-day moving average (22.62 euros), indicating a positive long-term trend. Over the past week, the stock has declined by 2.08% and shows a decrease of 13.31% over three months, correcting after a surge of more than 80% over a year. The most relevant technical support is around 22.56 euros, close to the lower Bollinger band. The monthly volatility remains contained at 21.16% with a beta of 0.61, reflecting moderate sensitivity to general market movements. The RSI, at 62, signals a stock in a neutral to slightly dynamic zone, without excessive buying or selling at this stage.
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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