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 individuals with Bipolar-I Disorder, highlighting its potential significance in addressing this challenging condition.
Intervention/Treatment: The study tests KarXT, an experimental drug, against a placebo. KarXT is designed to manage symptoms of mania in Bipolar-I Disorder, offering a potential new treatment option.
Study Design: This is an interventional study with a randomized, parallel assignment model. It employs double masking for both participants and investigators to ensure unbiased results. The primary purpose is treatment-focused.
Study Timeline: The study began on June 11, 2025, with its primary completion and estimated overall completion dates yet to be announced. The latest update was submitted on July 14, 2025, indicating ongoing recruitment efforts.
Market Implications: The progress of this study could influence Bristol-Myers Squibb’s stock performance, as successful results may enhance its market position in the psychiatric treatment sector. Investors should monitor developments closely, considering the competitive landscape in mental health therapies.
Closing Sentence: The study is currently recruiting, with further details available on the ClinicalTrials portal.