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Medincell Shares Surge 6.95% Midday Following Two Strategic Announcements

The biopharmaceutical company's stock crossed the 28 euros mark this Wednesday, December 10, at midday, driven by the publication of increased semi-annual results and particularly by the announcement of its partner Teva's regulatory filing with the FDA for Olanzapine LAI, a long-acting injectable treatment for schizophrenia.


Medincell Shares Surge 6.95% Midday Following Two Strategic Announcements

Impressive Midday Trading Performance

At 28.32 euros in the session this Wednesday, December 10, 2025, around noon, Medincell's stock has risen by 6.95% compared to the previous day (26.48 euros), extending a notable upward trend with an increase of 9.34% over a week, 52.26% over three months, and 68.77% over a year. The traded volumes represent 0.45% of the capital, reflecting a moderate but steady resurgence of interest. This session occurs against the backdrop of two major publications: the first semester 2025-2026 results showing a 50% increase in operating income to 14.1 million euros, and Teva's submission of a New Drug Application (NDA) to the FDA for Olanzapine LAI for the treatment of adult schizophrenia. This second catalyst marks a critical regulatory step for Medincell's portfolio.

Regulatory and Clinical Developments

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The application is based on the results of the phase 3 SOLARIS trial, including 56-week data demonstrating the efficacy, safety, and tolerance of the product in participants aged 18 to 64 with schizophrenia. After an NDA submission, the FDA typically takes about two months to determine the acceptance of the review, then an additional eight months for a standard review, positioning a possible approval in the fourth quarter of 2026. No cases of post-injection delirium or sedation syndrome (PDSS) were observed with Olanzapine LAI up to week 56 of the SOLARIS trial, a major competitive advantage over existing formulations. Analysts are closely monitoring this stage: CFO Stéphane Postic anticipates a revenue acceleration in the coming years thanks to Olanzapine LAI, while Jefferies raised its price target from 22 to 50 euros last November, reflecting the commercial potential of this molecule.

Technical Analysis of Stock Performance

Technically, the stock is now trading above its 200-day moving average (19.91 euros), confirming a structural bullish bias. The Relative Strength Index (RSI) at 28 indicates an oversold zone, partly explaining the rebound observed this Wednesday and suggesting additional room for growth before reaching overbought levels. However, the stock remains below the resistance of its 50-day moving average (30.83 euros), a level it must surpass to confirm a sustainable exit from its consolidation phase that began in late November. Trading volumes remain modest (0.45% of the capital), indicating the absence of selling pressure but also a consensus still under construction. With a support identified at 25.90 euros and a higher resistance at 38.46 euros, the stock has a technical corridor conducive to further appreciation, subject to regulatory and commercial confirmations in the coming quarters.



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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