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MedInCell Stock: Moderate Decline Despite Major Regulatory Progress in the U.S.

MedInCell shares fell 1.7% this Tuesday midday, trading at 24.26 euros on Euronext Paris. This decline occurs as the Montpellier-based biotech has just achieved a significant breakthrough in the U.S. with the FDA's acceptance of the registration file for its olanzapine-based injectable treatment. The price is moving below its 50-day moving average, in a context of consolidation after an outstanding annual performance of over 78%.


MedInCell Stock: Moderate Decline Despite Major Regulatory Progress in the U.S.

FDA Accepts Review of Olanzapine Injectable

The announcement came yesterday: the U.S. health agency has accepted to review the market authorization request for olanzapine LAI, a prolonged-release subcutaneous injection developed jointly by Teva Pharmaceuticals and MedInCell. This monthly treatment targets schizophrenia in adults and is part of the two partners' strategy around prolonged-action injectable drugs.

The FDA's acceptance of the file marks a key regulatory milestone, as it indicates that the agency considers the submission sufficiently complete to begin its evaluation process. This program represents one of the most advanced assets in MedInCell's portfolio and could, if approved, generate revenue in the form of royalties from U.S. sales. Financially, the company will publish its annual results for the fiscal year 2025-2026 on June 16th, which will allow assessing the financial impact of the various milestones achieved during the period.

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Technically, MedInCell's stock price is currently below its 50-day moving average, located at 25.46 euros, indicating short-term selling pressure after a decline of more than 14% over three months. However, the stock remains well above its 200-day moving average (22.66 euros), reflecting the strength of the long-term upward trend, supported by a nearly 78.4% increase over the year.

The RSI is positioned at 61, a level that signals a still favorable dynamic without overbuying, leaving room for movement in both directions. The most relevant support threshold is at 22.56 euros, a zone that has already served as a floor in recent weeks and approximately coincides with the long-term moving average. The monthly volatility of 21.29% and a beta of 0.40 further underline a profile relatively uncorrelated with major indices, a common characteristic of biotechnological values whose trajectory depends primarily on clinical and regulatory milestones.



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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