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Medincell's Stock Falls 21.5% Over the Week Despite Regulatory Progress

Medincell's stock has seen a significant decline of 21.5% over the past week, closing at 22.56 euros on Friday. This drop occurs in a context of high volatility, while the biotechnology company specializing in extended-release injectable formulations shows a contrasting performance with a three-month decline of 38.06%, but still posts a positive annual increase of 40.82%.


Medincell's Stock Falls 21.5% Over the Week Despite Regulatory Progress

Regulatory Milestone Announced for Olanzapine LAI

Medincell announced on Wednesday, through its partner Teva Pharmaceuticals, that the filing for marketing authorization for olanzapine LAI in Europe is scheduled for the second quarter of 2026. This extended-release injectable formulation, intended for the treatment of schizophrenia, is one of the major assets in the Montpellier-based biotech's portfolio. This announcement is part of Medincell's geographic expansion strategy, aiming to enter European regulated markets after making progress in the United States. Utilizing Teva, a leading laboratory in generics and biosimilars, ensures the French company access to the necessary commercial infrastructure for rapid market introduction once approval is obtained. This regulatory timeline represents an expected operational milestone to validate the commercial potential of Medincell’s proprietary technology based on biodegradable polymers.

Investment Bank Adjusts Medincell's Price Target

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On January 29, the investment bank Stifel revised its price target on Medincell, lowering it from 37 to 33 euros, while maintaining a 'accumulate' recommendation. This 10.8% adjustment reflects increased caution from analysts due to recent volatility, but still maintains a favorable outlook with a potential upside of 46% compared to the weekly closing price. However, this adjustment in expectations does not fully explain the extent of the observed stock decline. From a technical standpoint, the stock is now trading below its 20-day (26.23 euros) and 50-day (26.55 euros) moving averages, indicating persistent selling pressure. The RSI at 38 suggests approaching oversold territory, though not yet reaching critical levels. The monthly volatility at 22.78% reflects the uncertainty surrounding the stock, while the support identified at 15.63 euros represents a major psychological threshold in case of further declines. The resistance at 38.46 euros remains a distant target in the current unfavorable market environment for the biotechnology sector.



Sector Santé · Biotechnologies · Pharmacie Biotechnologie


Assurance vie

Context

Period
  • Period: 9M 2025
Guidance from the release
  • 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

The information presented in this article is provided for informational purposes only and does not constitute an investment recommendation, an incentive to buy or sell a financial asset, or investment advice. Readers are invited to conduct their own research before making any decision.

Investments in the stock market involve risks, including the risk of capital loss. Past performance of an asset or market is no guarantee of future results. Any investment decision should be made taking into account your personal financial situation, objectives and risk tolerance.

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