Bristol-Myers Squibb Company ((BMY)) announced an update on their ongoing clinical study.
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In a recent update, Bristol-Myers Squibb Company (BMY) announced the commencement of a Phase 3 clinical 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 individuals with Bipolar-I Disorder, marking a significant step in addressing this challenging condition.
The study is testing the drug KarXT, which is administered in flexible doses, against a placebo. KarXT is designed to manage symptoms of mania, offering a potential new treatment avenue for patients with Bipolar-I Disorder.
This interventional study employs a randomized, parallel assignment model with double masking for both participants and investigators. The primary goal is treatment-focused, with participants undergoing a three-week inpatient period to evaluate the drug’s effectiveness compared to a placebo.
The study officially started on June 11, 2025, with the last update submitted on July 14, 2025. These dates are crucial as they indicate the study’s progression and timeline for potential results, which investors closely watch.
The initiation of this study could influence Bristol-Myers Squibb’s stock performance positively, as successful results may enhance the company’s portfolio in the psychiatric treatment market. Investors should also consider the competitive landscape, as advancements in this area could impact market dynamics.
The study is currently recruiting, and further details are available on the ClinicalTrials portal.