Core Insights - Bristol Myers Squibb (BMY) shares increased by 5.62% following the announcement to continue the phase III ADEPT-2 study on Cobenfy for psychosis associated with Alzheimer's disease, contrary to investor expectations of a study failure [1][2][7] - The ADEPT-2 study's data readout has been postponed to next year, but the continuation of the study has reassured investors [2][7] - BMY's shares have declined by 9.9% year-to-date, while the industry has seen a growth of 19.9% [2] Study Details - The ADEPT-2 study is a multicenter, randomized, double-blind, placebo-controlled trial assessing the safety and efficacy of Cobenfy in patients with Alzheimer's disease dementia-related psychosis [4] - The primary endpoint focuses on changes in the Neuropsychiatric Inventory-Clinician Hallucinations and Delusions score, with a key secondary endpoint of Clinical Global Impression-Severity [5] - Irregularities were identified at a few study sites, leading to the exclusion of their data from the primary analysis after consultation with the FDA and a data monitoring committee (DMC) [6][7] Future Prospects - The DMC has recommended continuing the study by enrolling additional patients, and BMY will proceed with patient enrollment while remaining blinded to the study data [8] - Additional results from the ADEPT program, including ADEPT-1 and ADEPT-4, are expected by the end of 2026 [9] Portfolio Diversification - BMY is actively working to diversify its portfolio due to the negative impact of generics on its legacy drugs like Revlimid and Pomalyst [10] - The approval of Cobenfy has further diversified BMY's portfolio, with sales reaching $105 million year-to-date, and it is expected to be a significant growth driver as the company seeks label expansions [11] - The FDA has granted Fast Track Designation to BMS-986446, a potential anti-microtubule binding region-tau antibody currently in phase II development for early Alzheimer's disease [12]
BMY Gains on News of Continuation of Alzheimer's Disease Study