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Investing.com -- Bristol Myers Squibb (NYSE:BMY) stock rose 1.5% Wednesday after the company announced it will continue its ADEPT-2 Phase 3 study for psychosis associated with Alzheimer’s disease following a review of site-level data.
The pharmaceutical giant identified irregularities in clinical trial execution at a small number of study sites and decided to exclude data from those sites from the primary analysis. This decision was made prior to database lock, maintaining the integrity of the study.
Following consultation with the FDA, an independent party conducted an interim data analysis, which was reviewed by the Data Monitoring Committee (DMC). Based on the DMC’s recommendation, Bristol Myers Squibb will enroll additional patients to reach the original target study population.
"Our decision to exclude patient data from sites where irregularities were observed reflects our unwavering commitment to safeguarding the integrity of our studies," said Laura Gault, MD, PhD, Senior Vice President, Head of Development, Neuroscience Drug Development at Bristol Myers Squibb.
The company remains blinded to the study data as it moves forward with the trial. The drug being tested, Cobenfy, is currently approved for schizophrenia treatment in adults and could potentially become the first treatment in a new class targeting agitation and psychosis through muscarinic receptor agonism.
Results from the ADEPT program in psychosis associated with Alzheimer’s Disease, including ADEPT-2, ADEPT-1, and ADEPT-4, are expected by the end of 2026.
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