Medincell's Stock Climbs 3.85% at Close Following Teva's Regulatory Filing with the FDA
The biopharmaceutical company's stock closed at 27.50 euros this Wednesday, December 10, continuing its upward trend that began earlier in the week. This increase follows two major strategic announcements: the publication of strong half-year results and Teva's submission of a marketing authorization application to the FDA for Olanzapine LAI, a long-acting injectable treatment for schizophrenia. The stock has shown remarkable performance over three months and one year, supported by advances in its pipeline and enhanced visibility among institutional investors.
Significant Growth and Regulatory Milestones
At a closing price of 27.50 euros on Wednesday, December 10, 2025, Medincell's stock gained 3.85% compared to the previous day (26.48 euros), with volumes representing 0.82% of the traded capital. This increase is part of a broader upward trend: +6.18% over a week, +47.85% over three months, and +63.89% over a year. The stock benefits from two key announcements made the day before. Firstly, the results for the first half of 2025-2026 showed a 50% increase in operating revenue to 14.1 million euros, driven by a 35% increase in sales to 11.6 million euros. Secondly, Teva Pharmaceuticals, a partner of Medincell, filed a New Drug Application (NDA) with the FDA for Olanzapine LAI for the treatment of schizophrenia in adults. This regulatory step is a crucial milestone for the group's portfolio. The filing is based on the results of the phase 3 SOLARIS trial, including 56-week data demonstrating the efficacy, safety, and tolerability of the product in participants aged 18 to 64 with schizophrenia. No cases of post-injection delirium sedation syndrome (PDSS) were observed up to week 56, a major competitive advantage over existing formulations. Following the submission of an NDA, the FDA typically takes about two months to determine acceptance for review, then an additional eight months for a standard review, positioning a possible approval in the fourth quarter of 2026. CFO Stéphane Postic anticipates an acceleration of revenue 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.
Financial Performance and Strategic Developments
The first half of fiscal year 2025-2026 recorded operating revenue of 14.1 million euros, up 50%, and sales of 11.6 million euros, up 35%. However, the company posted a negative operating result of 6.6 million euros, despite a 13% improvement from the previous year. Operating expenses amounted to 20.8 million euros, up 22%, including 13.3 million euros in research and development expenses. Cash and cash equivalents stood at 49.8 million euros at the end of the semester, with 3.7 million euros in low-risk financial investments. The net cash flow from investment activities was mainly influenced by the sale of 9.1 million euros of investments. Medincell continues its strategic development with the anticipated launch of Olanzapine LAI next year, which is expected to be a major growth driver. The company is also expanding its portfolio with collaborations, including with AbbVie for a program whose regulatory dossier is planned for 2026. Additionally, Medincell has invested in several global health projects, supported by funding such as that from the Gates Foundation for programs against malaria and tuberculosis. The company notes that the weakness of the dollar against the euro has impacted its financial results. If this situation persists, operational profitability could be delayed beyond fiscal year 2026-2027.
Technical Analysis and Market Prospects
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. This setup indicates that the stock, although on a long-term upward trend, has undergone a recent correction that could pave the way for a new phase of appreciation. The stock remains below the resistance of its 50-day moving average (30.83 euros), a level it must surpass to confirm a sustained exit from its consolidation phase that began in late November. With support identified at 25.90 euros and higher resistance at 38.46 euros, the stock has a technical corridor conducive to continued appreciation, subject to regulatory and commercial confirmations in the coming quarters. Trading volumes of 0.82% of the capital remain modest, reflecting the absence of selling pressure but also a consensus still under construction. Medincell's entry into the MSCI World Small Cap index, effective since November 24, 2025, should increase the stock's visibility among institutional investors and funds that follow MSCI indices, potentially enhancing liquidity in the medium term.
