Bristol-Myers Squibb Company ((BMY)) announced an update on their ongoing clinical study.
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Bristol-Myers Squibb Company (BMY) is conducting a Phase 3, open-label extension study titled A Phase 3, Open-label Extension Study to Assess the Long-term Safety of KarXT for the Treatment of Mania or Mania With Mixed Features in Bipolar-I Disorder (BALSAM-3). The study aims to evaluate the long-term safety and tolerability of KarXT in treating mania or mania with mixed features associated with Bipolar-I Disorder (BP-I).
The intervention being tested is KarXT, an experimental drug, alongside other therapeutic drugs like Lithium, Valproate, and Lamotrigine. These are intended to manage manic episodes in patients with BP-I.
The study follows an interventional design with a single-group model and no masking, focusing primarily on treatment. This straightforward approach allows for direct assessment of the drug’s long-term safety.
The study began on April 14, 2025, with its latest update on October 22, 2025. These dates are crucial as they indicate the study’s progress and ongoing recruitment status.
This clinical update could influence BMY’s stock performance positively by demonstrating commitment to addressing mental health disorders, potentially boosting investor confidence. It also positions BMY competitively in the pharmaceutical industry, particularly in the psychiatric treatment market.
The study is currently recruiting, with further details available on the ClinicalTrials portal.
