Bristol-Myers Squibb Company ((BMY)) announced an update on their ongoing clinical study.
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Study Overview: Bristol-Myers Squibb is conducting a Phase 3 study titled ‘A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-1)’. The study aims to assess the efficacy and safety of KarXT in treating manic episodes in patients with Bipolar-I Disorder, marking a significant step in addressing this challenging condition.
Intervention/Treatment: The study tests KarXT, an experimental drug, against a placebo. KarXT is intended to manage symptoms of mania, offering a potential new treatment option for Bipolar-I Disorder.
Study Design: This interventional study is randomized and double-blind, meaning neither participants nor investigators know who receives the drug or placebo. It follows a parallel assignment model with the primary purpose of treatment, ensuring robust and unbiased results.
Study Timeline: The study began on June 11, 2025, with primary completion expected within a three-week inpatient period. The last update was on July 29, 2025. These dates are crucial for tracking progress and anticipating results.
Market Implications: This study could significantly impact Bristol-Myers Squibb’s stock performance and investor sentiment, as successful results may enhance the company’s portfolio in the psychiatric treatment market. Competitors in the mental health sector will be closely monitoring these developments.
The study is ongoing, with further details available on the ClinicalTrials portal.