Bristol-Myers Squibb Company ((BMY)) announced an update on their ongoing clinical study.
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In a significant development, Bristol-Myers Squibb Company (BMY) is conducting a Phase 3 clinical study titled ‘A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-2)’. The primary goal is to assess the effectiveness of KarXT in alleviating manic symptoms in individuals with Bipolar-I disorder over a three-week inpatient period. This study is crucial as it aims to address the challenges faced by patients experiencing acute manic episodes.
The study is testing an experimental drug, KarXT, against a placebo. KarXT is designed to manage manic symptoms in Bipolar-I disorder, potentially offering a new treatment option for patients.
This interventional study is randomized and double-blind, meaning neither the participants nor the investigators know who receives the actual drug or placebo. It uses a parallel assignment model with the primary purpose of treatment.
The study began on June 13, 2025, with an estimated primary completion date not yet disclosed. The last update was submitted on July 22, 2025. These dates are crucial for tracking the study’s progress and anticipating results.
The outcome of this study could significantly influence Bristol-Myers Squibb’s stock performance, as successful results may enhance investor confidence and position the company favorably against competitors in the psychiatric treatment market.
The study is currently recruiting, with further details available on the ClinicalTrials portal.