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Medincell Stock: Surge of 14.36% Following FDA Approval

The biotech company from Montpellier shows a marked increase at the opening this Monday morning, driven by a US regulatory announcement made last Friday evening.


Medincell Stock: Surge of 14.36% Following FDA Approval

Significant Opening Surge

Medincell's stock opened at 31.38 euros, up 14.36% from last Friday's close of 27.44 euros. This morning's performance extends an already well-established upward trend: the stock has gained 18.06% over the past seven days and 95.64% over three months. Over the past year, the increase has reached 106.4%, which is twenty times higher than that of the CAC 40 (+5.02% over the same period). The traded volumes represent 0.67% of the capital, a level of activity that reflects significant investor interest this morning, while the Paris index itself is up by 0.51%. The surge in the stock follows the announcement on Friday evening by the Food and Drug Administration of the approval of the expanded indication of Uzedy for the treatment of type 1 bipolar disorder in adults. This antipsychotic medication, developed in partnership with the Israeli laboratory Teva, was previously authorized only for schizophrenia. This new indication significantly broadens the potential market for the product, considering that about 1% of American adults, or more than 3.4 million people, are affected by this pathology. Following this announcement, the financial intermediary TP ICAP Midcap raised its price target on Medincell from 27 euros to 32 euros, while maintaining its buy recommendation.

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From a technical standpoint, the price now significantly exceeds the resistance level which was at 28.64 euros, a breakthrough that theoretically opens the way for a continuation of the upward movement. The Relative Strength Index has reached 84, a level that places the stock in an overbought zone according to usual criteria for reading this indicator, signaling that the recent rise has been particularly rapid and intense. The Chaikin Money Flow, which measures buying or selling pressure taking into account volumes, shows a positive value of 0.14, confirming that buying flows remain dominant over the recent period. The MACD, which compares two exponential moving averages to detect momentum changes, is at 2.38 against 2.01 for its signal line, with a positive histogram of 0.37. This configuration indicates an active bullish momentum at this stage. The stock is trading well above its 50-day moving average, positioned at 19.83 euros, and even more clearly above its 200-day moving average established at 16.52 euros, both benchmarks confirming a long-term bullish trend over several months. The volatility measured over a month is at 9.82%, a relatively moderate level given the amplitude of recent variations, while the beta of -0.07 indicates a very low correlation with the movements of the CAC 40.

Current Technical Indicators

The Bollinger Bands currently frame the fluctuations of the stock between 18.22 euros for the lower bound and 29.35 euros for the upper bound, but the price has crossed this latter this morning, which may signal either an extension of volatility or an acceleration of the ongoing movement. The Average True Range, which measures the average daily variation amplitude, is established at 0.64 euro, reflecting significant daily oscillations in the current context. The nearest technical support now stands at 16.89 euros, nearly 46% below the current price, a significant distance that illustrates the ground covered by the stock since its levels last summer.



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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