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MEDINCELL Shares Climb 2.2% at Close, Boosted by Consecutive Regulatory Approvals

MedinCell closed Tuesday, October 28, with a gain, reaching 37.12 euros. The French biotech company, specializing in extended-release injectable formulations, continues its rebound that began in early October, supported by recent regulatory approvals in the United States and Canada. This momentum is particularly reflected in the company's participation at the Truist Securities Biopharma Symposium 2025 in New York.


MEDINCELL Shares Climb 2.2% at Close, Boosted by Consecutive Regulatory Approvals

Stock Performance Overview

The stock rose by 2.2% from the previous day (36.32 euros) and has accumulated a gain of 5.64% over the past seven days, confirming a marked acceleration since the beginning of the month. This performance places MedinCell well ahead of benchmark indices: the CAC 40 fell by 0.27% for the day and rose by 9.59% over twelve months, leaving this growth stock far behind. Since January 2025, MedinCell has appreciated by 103.97%, while the annual gain reached 146.5%, reflecting a substantial revaluation of the stock over recent quarters. The market capitalization now stands at 1.115 billion euros, reflecting growing recognition of the company's commercial and technological potential. However, capital turnover remains moderate at 0.34% for the day, suggesting that this bullish movement is more a result of strategic reallocation of existing positions than a true influx of new capital. Over three months, MedinCell has accumulated a gain of 116.9%, a tangible illustration of a break in the stock's perception by the investment community in recent quarters.

Regulatory Catalysts Multiply

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Regulatory catalysts have increased since the beginning of October. On October 10, the FDA approved the indication extension of UZEDY® (developed in collaboration with Teva Pharmaceutical Industries) for the treatment of type I bipolar disorder, expanding the therapeutic potential of this injectable product. This approval comes in a context of gradual recognition of extended-release injectables as a structural component of psychiatric therapeutic strategies. This regulatory movement continues from the approval obtained in Canada for LONGAVO® (injectable risperidone) on September 23, marking a tangible acceleration of institutional validation of technologies developed by MedinCell among major global regulators. These two consecutive approvals focus on the biotech's injectable portfolio, confirming the strategic relevance of this technological orientation towards extended-release formulations and consolidating the credibility of the company's business model.

Technical Analysis and Market Sentiment

Technically, MedinCell displays an advanced bullish extension configuration. The RSI reaches 78, indicating an overbought condition that suggests a possible short-term fatigue. The stock is trading well above its moving averages (MM50 at 23.85 euros and MM200 at 17.49 euros), confirming a solidly established bullish trend. The Bollinger Bands (upper: 39.14 euros; lower: 22.64 euros) position the stock at the top of its technical envelope, characteristic of an environment of maximized volatility. However, the consensus among analysts points to a target price of 33.24 euros for the next three months, implying a potential downside of 8.47% from current levels. This gap raises questions about the sustainability of the movement and the pace of realization of the biotech's commercial ambitions.



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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