Regulatory News:
Medincell (Euronext Paris: MEDCL) partner, Teva Pharmaceuticals (NYSE and TASE: TEVA), announced today that UZEDY U.S. net sales reached $63 million in Q1 2026, representing a 62% increase from $39 million in Q1 2025 and a 15% increase from $55 million in Q4 2025.
Medincell receives mid- to high-single-digit royalties on UZEDY net sales and is eligible for up to $105M in commercial milestone payments, subject to the achievement of annual sales thresholds.
UZEDY is a 1-Month and 2-Month subcutaneous risperidone LAI (Long-Acting Injectable). It received U.S. FDA approval for schizophrenia in April 2023 and for Bipolar I Disorder in October 2025.
Olanzapine LAI
The New Drug Application (NDA) for once-monthly olanzapine LAI for the treatment of schizophrenia in adults was accepted by the U.S. FDA in February 2026, with a regulatory decision anticipated in Q4 2026. In Europe, acceptance of the Marketing Authorization Application (MAA) is expected in Q2 2026.
Teva Q1'26 results press release: https://ir.tevapharm.com/news-and-events/press-releases/default.aspx
Teva Q1'26 earnings conference call today at 8:00am ET: https://events.q4inc.com/attendee/621165544
About Medincell
Medincell is a clinical- and commercial-stage biopharmaceutical licensing company developing long-acting injectable treatments across multiple therapeutic areas. Our innovative treatments are designed to ensure adherence to medical prescriptions, enhance the effectiveness and accessibility of medicines, and reduce their environmental impact.
These treatments combine active pharmaceutical ingredients with our proprietary BEPO BEPO Star technologies, which enables controlled drug delivery at therapeutic levels for several days, weeks, or months following a subcutaneous or local injection of a small, fully bioresorbable depot.
Risperidone LAI was the first treatment based on BEPO technology to receive FDA approval, initially for schizophrenia in April 2023, and subsequently for Bipolar I Disorder in October 2025. It is marketed in the United States by Teva under the brand name UZEDY. Medincell's risperidone LAI was also approved for schizophrenia in Canada and South Korea in 2025.
A New Drug Application (NDA) for Olanzapine LAI as a once-monthly treatment for schizophrenia in adults was submitted to the U.S. FDA in December 2025 by Medincell's partner, Teva. U.S. FDA accepts Teva's New NDA for Olanzapine LAI on February 20, 2026.
Medincell's investigational pipeline includes numerous innovative therapeutic candidates in various stages of development, from formulation to Phase 3 clinical trials. We collaborate with leading pharmaceutical companies and foundations to advance global health through new treatment options.
Headquartered in Montpellier, France, Medincell employs over 140 people representing more than 25 nationalities.
medincell.com
UZEDY is a trademark of Teva Pharmaceuticals. Medincell's BEPO technology is licensed to Teva as SteadyTeq, a trademark of Teva Pharmaceuticals.
This press release may contain forward-looking statements, particularly concerning the progress of the Company's clinical trials. Although the Company considers that its forecasts are based on reasonable assumptions, any statements other than statements of historical fact that may be contained in this press release relating to future events are subject to change without notice, to factors beyond the Company's control and to the Company's financial capabilities.
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A list and description of such risks, hazards and uncertainties can be found in the documents filed by the Company with the Autorité des Marchés Financiers (AMF) pursuant to its regulatory obligations, including in the Company's document de base, registered with the AMF on September 4, 2018 under number I. 18-062, as well as in documents and reports to be published subsequently by the Company. Furthermore, these forward-looking statements only apply as of the date of this press release. Readers are cautioned not to place undue reliance on these forward-looking statements. Except as required by law, the Company undertakes no obligation to publicly update these forward-looking statements, nor to update the reasons why actual results may differ materially from those anticipated in the forward-looking statements, even if new information becomes available. The Company's updating of one or more forward-looking statements does not imply that it will or will not update these or any other forward-looking statements.
This press release is published for information purposes only. The information contained herein does not constitute an offer to sell or a solicitation of an offer to buy or subscribe for securities of the Company in any jurisdiction whatsoever, particularly in France. Similarly, this press release does not constitute investment advice and should not be treated as such. It is not intended to address the investment objectives, financial situation or specific needs of any particular recipient. It should not be relied upon as a substitute for the exercise of your own judgement. All opinions expressed in this document are subject to change without notice. The distribution of this press release may be restricted by law in certain jurisdictions. Persons into whose possession this press release comes are required to inform themselves about and to observe any such restrictions.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260429403522/en/
Contacts:
David Heuzé
Head of Corporate and Financial Communications, and ESG
david.heuze@Medincell.com +33 (0)6 83 25 21 86
Grace Kim
Chief Strategy Officer, U.S. Finance
grace.kim@medincell.com +1 (646) 991-4023
Nicolas Mérigeau Arthur Rouillé
Media Relations
Medincell@newcap.eu +33 (0)1 44 71 94 94
Louis-Victor Delouvrier Alban Dufumier
Investor Relations France
Medincell@newcap.eu +33 (0)1 44 71 94 94
