Medincell: FDA Approves UZEDY for Treatment of Bipolar I Disorder on October 10
The FDA has approved the use of UZEDY, an extended-release injectable suspension of risperidone, for the treatment of Bipolar I Disorder (BD-I) in adults.
The press release does not provide financial details regarding Medincell's performance following this approval. It primarily focuses on the regulatory approval of the product. Therefore, no numerical data related to sales, margins, or net profits are mentioned in this recent announcement.
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Medincell, in collaboration with Teva Pharmaceuticals, announced that the FDA's approval for UZEDY is based on existing clinical data and drug development methodologies informed by model-informed drug development (MIDD). This extended-release formulation of risperidone is administered subcutaneously and utilizes Medincell's SteadyTeq™ technology. UZEDY is available in three monthly dosages of 50 mg, 75 mg, and 100 mg. This breakthrough marks the first subcutaneous, extended-release formulation of risperidone.
Bipolar I Disorder affects approximately 1% of American adults, amounting to over 3.4 million individuals. The disorder is associated with poor long-term outcomes and increased mortality. The new formulation of UZEDY could potentially improve treatment adherence, which is often a challenge in the effective management of this disease. Medincell hopes that the approval of this new use of UZEDY will help meet the unmet needs of patients living with Bipolar I Disorder.
We are pleased with the company’s growth and momentum.
Total income €14,1 million; Revenues €11,6 million (+35 %); UZEDY® royalties €4,2 million; Operating result €(6,6) million (improved 13 % year-over-year); Net result €(16 078) thousand; Cash and low-risk financial investments €53,5 million (incl. €49,8 million cash and €3,7 million low-risk investments); Net financial debt €17 629 thousand; NDA for Olanzapine LAI submitted to FDA on December 9, 2025; AbbVie partnership advancing with regulatory package expected in 2026.
Risks mentioned
Foreign exchange risk: weakness of USD vs EUR impacted revenues and generated ~€1 million FX losses
Dependency on partner commercialization (Teva) for UZEDY® royalties and sales forecasts
Regulatory risk: approvals (e.g., Olanzapine LAI) and acceptance for review uncertain
Financial volatility linked to fair value revaluation of EIB BSA warrants (non-cash €6,8 million impact)
Opportunities identified
Olanzapine LAI: NDA submitted and potential launch could be a major growth catalyst
UZEDY®: upward revision of 2025 net sales forecast by Teva (from $160 million to $190-200 million)
AbbVie partnership: first program advancing toward first-in-human trials (regulatory package expected 2026)
Gates Foundation financing: new $3 million envelope to advance mdc-STM malaria program
Expanded geographic approvals (Canada, South Korea) supporting broader commercialization
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