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PARSIPPANY, N.J. - The U.S. Food and Drug Administration has approved UZEDY (risperidone) extended-release injectable suspension for the maintenance treatment of bipolar I disorder in adults, Teva Pharmaceuticals (NYSE:TEVA) and MedinCell (Euronext:MEDCL) announced Friday. MedinCell’s stock has shown remarkable momentum, with a 119% surge over the past six months, according to InvestingPro data. The company’s shares are currently trading near their 52-week high, suggesting strong market confidence in this development.
The approval allows UZEDY to be used as monotherapy or as adjunctive therapy to lithium or valproate. The medication will be available in three once-monthly dosing options of 50 mg, 75 mg, and 100 mg. While MedinCell has demonstrated impressive revenue growth of 132% in the last twelve months, InvestingPro analysis indicates the company is currently trading above its Fair Value, with 14 additional ProTips available for subscribers.
UZEDY, which was previously approved in 2023 for schizophrenia treatment in adults, is the first subcutaneous long-acting formulation of risperidone that utilizes SteadyTeq, a proprietary copolymer technology from MedinCell that controls the steady release of the medication.
The FDA based its decision on existing clinical data for UZEDY coupled with Model-Informed Drug Development methodologies that leverage previous findings on risperidone formulations already approved for bipolar I disorder.
"Adults living with BD-I experience debilitating manic and depressive symptoms, and today’s FDA approval of UZEDY provides a new long-acting formulation of risperidone that may help address existing unmet needs and treatment gaps," said Chris Fox, Executive Vice President, U.S. Commercial at Teva, according to the company’s press release.
Bipolar I disorder affects approximately 1% of U.S. adults, or more than 3.4 million people. The condition is associated with poor long-term outcomes and increased mortality compared to the general population. From a financial perspective, MedinCell maintains a healthy liquidity position with a current ratio of 2.7, indicating strong ability to meet short-term obligations as it pursues this market opportunity.
UZEDY delivers therapeutic blood concentrations within 6-24 hours of a single dose and is available in both one- and two-month dosing intervals for schizophrenia treatment.
Common side effects reported in clinical trials include slow movements, stiffness, shaking, weight gain, and injection site reactions. As MedinCell continues to expand its commercial presence, investors should note that while the company operates with moderate debt levels, analysts tracked by InvestingPro do not anticipate profitability this year, though the company maintains strong growth momentum.
In other recent news, Teva has shared promising data from its Phase 3 SOLARIS trial for the investigational once-monthly subcutaneous long-acting injectable olanzapine (TEV-749). The trial results, presented at the 2025 Psych Congress, revealed no suspected or confirmed Post-injection Delirium/Sedation Syndrome (PDSS) events through week 56. The safety profile of this treatment was consistent with other olanzapine formulations, with weight increase, injection site reactions, and somnolence being the most common adverse events reported. Meanwhile, Medincell has announced the appointment of three new independent board members. The new board members are Dr. Sharon Mates, Dr. Charles Kunsch, and Dr. Pascal Touchon, each bringing extensive experience from leadership roles in prominent biotech companies. Dr. Mates is noted for her role as co-founder and former CEO of Intra-Cellular Therapies, which was acquired by Johnson & Johnson. Dr. Kunsch has a background with AbbVie Ventures, and Dr. Touchon has held leadership positions at Novartis Oncology and Atara Biotherapeutics. These developments mark significant strides for both companies in their respective fields.
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