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 patients with Bipolar-I Disorder, a significant area of unmet medical need.
Intervention/Treatment: The study tests KarXT, an experimental drug, against a placebo. KarXT is being evaluated for its potential to alleviate symptoms of mania in Bipolar-I Disorder patients.
Study Design: This is a randomized, double-blind, placebo-controlled study with a parallel intervention model. Both participants and investigators are blinded to the treatment allocation. The primary goal is to determine the treatment efficacy.
Study Timeline: The study began on June 11, 2025, with an anticipated primary completion within three weeks of the inpatient treatment period. The last update was submitted on August 19, 2025, indicating ongoing recruitment.
Market Implications: The successful development of KarXT could significantly impact Bristol-Myers Squibb’s market position, potentially boosting its stock performance. Investors should watch for results, as positive outcomes could influence the competitive landscape in treating Bipolar-I Disorder.
The study is currently recruiting, with further details available on the ClinicalTrials portal.