-

Medincell’s partner Teva provides update on pivotal clinical Phase 3 of investigational Olanzapine Long-Acting Injectable (LAI) and UZEDY® commercial progress

MONTPELLIER, France--(BUSINESS WIRE)--Medincell (Paris:MEDCL):

Olanzapine LAI (mdc-TJK)

  • No PDSS* observed after completion of c.95% of the targeted injections for submission
  • Full phase 3 safety results on track for H2 2024
  • Positive phase 3 efficacy results have already been announced in May 2024 (read the full PR)

UZEDY®

  • Reaffirming revenue guidance for 2024: c.$80 million
  • Exploring an additional indication for UZEDY® for the treatment of Bipolar I Disorder in adults

ACCESS HERE THE FULL PRESS RELEASE

*PDSS = Post injection Delirium/Sedation Syndrome

About Medincell

Medincell is a clinical- and commercial-stage biopharmaceutical licensing company developing long-acting injectable drugs in many therapeutic areas. Our innovative treatments aim to guarantee compliance with medical prescriptions, to improve the effectiveness and accessibility of medicines, and to reduce their environmental footprint. They combine active pharmaceutical ingredients with our proprietary BEPO® technology which controls the delivery of a drug at a therapeutic level for several days, weeks or months from the subcutaneous or local injection of a simple deposit of a few millimeters, entirely bioresorbable. The first treatment based on BEPO® technology, intended for the treatment of schizophrenia, was approved by the FDA in April 2023, and is now distributed in the United States by Teva under the name UZEDY® (BEPO® technology is licensed to Teva under the name SteadyTeq™). We collaborate with leading pharmaceutical companies and foundations to improve global health through new treatment options. Based in Montpellier, Medincell currently employs more than 140 people representing more than 25 different nationalities.

UZEDY® and SteadyTeq™ are registered trademarks of Teva Pharmaceuticals.

www.medincell.com

Contacts

David Heuzé - Head of Corporate and Financial Communications, and ESG
david.heuze@medincell.com / +33 (0)6 83 25 21 86

Grace Kim - Head of US Financial Strategy and IR
grace.kim@medincell.com / +1 (646) 991-4023

Investors Relations France
Louis-Victor Delouvrier/Alban Dufumier
medincell@newcap.eu / +33 (0)1 44 71 94 94

Media Relations
Nicolas Mérigeau
medincell@newcap.eu / +33 (0)1 44 71 94 94

Medincell

BOURSE:MEDCL

Release Versions

Contacts

David Heuzé - Head of Corporate and Financial Communications, and ESG
david.heuze@medincell.com / +33 (0)6 83 25 21 86

Grace Kim - Head of US Financial Strategy and IR
grace.kim@medincell.com / +1 (646) 991-4023

Investors Relations France
Louis-Victor Delouvrier/Alban Dufumier
medincell@newcap.eu / +33 (0)1 44 71 94 94

Media Relations
Nicolas Mérigeau
medincell@newcap.eu / +33 (0)1 44 71 94 94

More News From Medincell

Medincell to Present at the TD Cowen 46th Annual Healthcare Conference in Boston, March 2-4, 2026

MONTPELLIER, France--(BUSINESS WIRE)--Regulatory News: Medincell (Euronext Paris: MEDCL), a commercial- and clinical-stage biopharmaceutical licensing company developing long-acting injectable treatments (the "Company"), today announced its participation at the TD Cowen 46th Annual Healthcare Conference, which will take place March 2-4, 2026 in Boston. The Company will present on Tuesday, March 3, 2026, at 1:50pm ET. Investor meetings with Dr Grace Kim, Chief Strategy Officer, U.S. Finance, may...

Medincell: U.S. Food and Drug Administration (FDA) Accepts Teva’s New Drug Application (NDA) for Olanzapine Extended-Release Injectable Suspension (TEV-'749) for the Once-Monthly Treatment of Schizophrenia in Adults

PARSIPPANY, N.J. & TEL AVIV, Israel & PARIS--(BUSINESS WIRE)--Regulatory News: Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), and Medincell (Euronext: MEDCL), announced today that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for olanzapine extended-release injectable suspension (TEV-'749) for the treatment of schizophrenia in adults. TEV-'749 is designed to improve real-world treatment adherence and...

Medincell’s ISS ESG Corporate Rating Upgraded

MONTPELLIER, France--(BUSINESS WIRE)--Regulatory News: Medincell (Euronext Paris: MEDCL), a commercial- and clinical-stage biopharmaceutical licensing company developing long-acting injectable treatments, today announces that ISS has upgraded the company’s ESG rating from C+ to B. Medincell is ranked within the first decile of the Pharmaceuticals & Biotechnology sector, benefits from ISS ESG Prime Status, and achieves a very high level of ESG disclosure transparency. This updated rating is...
Back to Newsroom