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, a significant step in addressing mental health challenges.
Intervention/Treatment: The study tests KarXT, an experimental drug, against a placebo. KarXT is intended to manage symptoms of mania in Bipolar-I Disorder patients.
Study Design: This interventional study is randomized and uses a parallel assignment model. It employs double masking, meaning both participants and investigators are unaware of who receives the treatment or placebo. The primary goal is treatment-focused.
Study Timeline: The study began on June 11, 2025, with a primary completion date yet to be announced. The latest update was submitted on August 19, 2025, indicating ongoing recruitment and progress.
Market Implications: The successful outcome of this study could positively impact Bristol-Myers Squibb’s stock performance by enhancing its portfolio in the mental health sector. This development could also influence investor sentiment positively, especially in comparison to competitors lacking similar advancements.
The study is currently ongoing, with further details available on the ClinicalTrials portal.