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 open-label extension study titled ‘A Study to Evaluate the Long-term Efficacy and Safety of KarXT + KarX-EC for Agitation in Alzheimer’s Disease (ADAGIO-3)’. The study aims to assess the long-term safety and effectiveness of the drug combination KarXT and KarX-EC in treating agitation in Alzheimer’s patients who have completed previous related studies. This research is significant as it addresses a critical need for effective treatments for agitation in Alzheimer’s disease.
Intervention/Treatment: The study tests a combination of drugs: KarXT, an immediate-release capsule, and KarX-EC, an enteric capsule. Both are designed to manage agitation symptoms in Alzheimer’s patients, potentially offering a new therapeutic option.
Study Design: This interventional study is non-randomized and follows a single-group model without masking, meaning all participants receive the treatment and both researchers and participants know what treatment is administered. The primary goal is treatment-focused, aiming to evaluate the drugs’ long-term efficacy and safety.
Study Timeline: The study is set to start on November 21, 2025, with this date being an estimate. It was first submitted on April 15, 2025, and last updated on August 19, 2025. These dates are crucial for tracking the study’s progress and anticipated milestones.
Market Implications: The update on this study could influence Bristol-Myers Squibb’s stock performance positively, as successful outcomes may lead to a new product in their portfolio, enhancing their market position. Investors might view this as a potential growth opportunity, especially given the high demand for effective Alzheimer’s treatments. Competitors in the pharmaceutical industry will likely monitor these developments closely, as advancements in Alzheimer’s treatment are highly competitive and impactful.
The study is ongoing, with further details available on the ClinicalTrials portal.