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MedinCell (MEDCL) investor relations material
MedinCell Status Update summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Status Update summary22 Sep, 2025
Key clinical findings
No cases of post-injection delirium/sedation syndrome (PDSS) were observed through week 56 in the pivotal Phase 3 SOLARIS trial for olanzapine LAI, supporting a favorable safety profile.
The long-term systemic safety profile of olanzapine LAI was consistent with other olanzapine formulations, with most common adverse events being weight increase, injection site reactions, and somnolence.
Serious adverse events occurred in 6% of participants, and 8% discontinued due to treatment-emergent adverse events.
Long-term effectiveness data showed maintained symptom improvement and stable clinical effectiveness, with improvements in PANSS, CGI-S, and PSP scores.
Weight and metabolic changes were comparable to existing oral and intramuscular olanzapine formulations, with mean weight gain stabilizing after 32 weeks.
Regulatory and commercial update
Teva plans to submit a New Drug Application (NDA) for olanzapine LAI in the US in Q4 2025, aiming to address a critical treatment gap in schizophrenia.
Olanzapine LAI is the second product in the Teva partnership using Medincell's co-polymer technology, following the FDA-approved UZEDY®.
Medincell is entitled to royalties on net sales and milestone payments upon commercialization.
Technology and innovation
Olanzapine LAI uses Steady Teq™, a proprietary copolymer technology enabling controlled, steady drug release throughout the dosing interval.
The formulation is designed to eliminate the risk of PDSS, potentially improving safety and accessibility for patients.
Quantify the market impact of no PDSS.
Medincell's revenue potential from Olanzapine LAI.
How does Olanzapine LAI differentiate from competitors?
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Next MedinCell earnings date
H1 25/269 Dec, 2025
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Frequently asked questions
MedinCell S.A. is a pharmaceutical company specializing in the development of long-acting injectable therapies using its proprietary BEPO technology. This technology allows for the sustained release of active pharmaceutical ingredients over several days, weeks, or months from a single, bioresorbable injection. The company's portfolio includes products targeting various therapeutic areas, with a focus on treating conditions such as schizophrenia and post-surgical pain. MedinCell collaborates with global pharmaceutical companies and organizations to advance its product pipeline. The company is headquartered in Jacou, France, and its shares are listed on the Euronext Paris.
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