(News Bulletin 247) – The American drug agency has given the green light to the marketing in the United States of the product developed by Medincell to treat bipolar disorders, based on a sustained-release formulation of risperidone.

Medincell and its partner Teva announce good news for Uzedy. The American health agency has just given approval to extend the use of this treatment to a new application in complex mental disorders.

The Lunel-based biotech, in fact, announced Friday, October 10 after market trading that the Food and Drug Administration (FDA) had given the green light to an extension of the indication of the treatment for bipolar disorder type I (BD-I) in adults administered once a month as monotherapy or in combination with lithium or valproate. This news is gratified on the stock market by a rebound in the stock of 17.3% to 32 euros around 3:10 p.m. Monday October 13.

Since May 2023, this treatment has already been approved in the United States for the treatment of schizophrenia in adults by monthly or bimonthly subcutaneous injection.

Uzedy is the first long-acting subcutaneous formulation of risperidone that uses SteadyTeq, Medincell’s proprietary copolymer-based technology that controls the steady release of risperidone.

Avoiding treatment omissions

This formulation achieves therapeutic plasma concentrations within 6 to 24 hours following administration of a single dose. Once the patient’s tolerance to oral risperidone is determined, the doctor decides on the dosing interval, either once a month or once every two months.

It is therefore a new innovative treatment for bipolar disorders which will benefit North American patients. Medincell recalls that approximately 1% of American adults (or more than 3.4 million people) will develop bipolar I disorder during their lifetime, a diagnosis associated with long-term deterioration of the patient and a substantial increase in mortality compared to the general population, both from suicide and from cardiovascular disease.

For bipolar disorders, this gradual release injection technology is adapted to this pathology. Patients are generally not able to realize their illness and its consequences.

Medincell reiterates that bipolar I disorder has profound implications on the patient’s life and is associated with suboptimal long-term outcomes, with adherence to daily oral treatment frequently representing a major barrier to effective management.

“The FDA’s approval to extend Uzedy’s recommendation supports and strengthens the strategy of the two partner groups to develop sustained-release psychiatric treatments,” notes Invest Securities.

Other indications to come

For its part, TP ICAP Midcap says it is confident in the product’s ability to be quickly prescribed to bipolar patients since the practitioners are often the same for the monitoring of schizophrenic and bipolar disorders.

The announcement will also benefit Medincell financially. The research office believes that this new indication should contribute to the sales dynamic and thus to the receipt of commercial royalty and milestone income on the Medincell side.

Last year, the marketing of Uzedy got off to a “more than promising” start, TP ICAP also recalls, since sales actually exceeded expectations in 2024 at $117 million, compared to $80 million targeted at the start of 2024. Over the first half of 2025, revenues linked to Uzedy stood at $93 million, leading Teva managers to raise their 2025 sales target for Uzedy between $190 million and $200 million, where the company previously targeted $160 million.

The research office expects that this new annual sales objective for Uzedy will probably be exceeded, on the occasion of the publication of Teva’s turnover scheduled for November 5.

In September, Medincell indicated that Uzedy had been approved in South Korea, and that this drug would be marketed by Teva Handok, a joint venture between Teva (Medincell’s partner) and Handok, a major player in the health sector in Korea.

According to TP ICAP Midcap, other areas should probably follow, identifying potential in other Asian countries, Latin America, Europe and the Middle East.

“Uzedy’s good commercial performance should make it possible to significantly increase the royalties received and trigger the payment of commercial milestones”, which confirms the research office in its turnover forecast of 43.4 million euros for 2025-2026.

The financial intermediary reiterates its purchase opinion and raises its price target from 27 euros to 30 euros to take into account the series of good news on the Teva side. He cites the more than promising results of Olanzapine phase III data, in schizophrenia and growth relay for Uzedy.