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 effectiveness and safety of KarXT in treating manic episodes in individuals with Bipolar-I Disorder, highlighting its potential significance in improving mental health treatments.
Intervention/Treatment: The study tests KarXT, an experimental drug, against a placebo. KarXT is intended to manage symptoms of mania in Bipolar-I Disorder, offering a potential new treatment option for patients.
Study Design: This interventional study is randomized and employs a parallel assignment model. It is double-blind, meaning neither participants nor investigators know who receives the drug or placebo, ensuring unbiased results. The primary purpose is treatment-focused, aiming to evaluate KarXT’s efficacy.
Study Timeline: The study began on June 11, 2025, with primary completion expected within three weeks of the inpatient period. The last update was on July 29, 2025, indicating ongoing recruitment and progress.
Market Implications: This study’s progress could influence Bristol-Myers Squibb’s stock performance, as successful results may boost investor confidence and market position in the mental health treatment sector. Competitors in the pharmaceutical industry will likely monitor these developments closely.
The study is ongoing, with further details available on the ClinicalTrials portal.