MONTPELLIER, France--(BUSINESS WIRE)--Regulatory News:
Medincell (Paris:MEDCL):
Christophe Douat, CEO of MedinCell, said: “The initiation of coverage by HC Wainwright's equity research team and their recommendation represent a significant validation of our company's potential. It underscores the growing interest in Medincell within the U.S. biopharmaceutical sector and strengthens our strategic objective to enhance our visibility among American investors.”
The initiation of coverage by HC Wainwright & Co. occurs as MedinCell has recently reached significant milestones, notably:
- US FDA approval and succesfull market launch by Teva of UZEDY® for maintenance treatment of schizophgrenia in May 2023. UZEDY® is the first royalty-generating product based on MedinCell’s long-acting injectable (LAI) technology approved;
- Positive Phase 3 efficacy results evaluating mdc-TJK, a second antipsychotic LAI developed with Teva, announced in May 2024. Mdc-TJK aims to be the first long-acting injectable of olanzapine with a favorable safety profile that could enable a large adoption for treatment of patients with more severe forms of schizophrenia. The comprehensive Phase 3 safety data package is expected in H2 2024;
- Start of a collaboration with AbbVie to co-develop and commercialize up to six therapeutic products across multiple therapeutic areas and indications announced in April 2024.
H.C. Wainwright & Co. is one of the U.S. oldest and most trusted financial institutions. www.hcwco.com
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.
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.
These statements may include, but are not limited to, any statements beginning with, followed by or including words or expressions such as "objective", "believe", "expect", "aim", "intend", "may", "anticipate", "estimate", "plan", "project", "will", "may", "probably", "should", "could" and other words or expressions of similar meaning or used in the negative. Forward-looking statements are subject to inherent risks and uncertainties beyond the Company's control which may cause actual results, performance or achievements of the Company to differ materially from those anticipated or implied by such statements.
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.
