Key Takeaways Bristol Myers gained FDA approval to extend Breyanzi's use to relapsed or refractory MZL.Breyanzi is now the only FDA-approved CAR T therapy covering five cancer types.Breyanzi sales reached $966M in the first nine months of 2025 on strong U.S. and international demand.Bristol Myers Squibb (BMY) recently obtained FDA approval for the label expansion of Breyanzi (lisocabtagene maraleucel) for the treatment of adult patients with relapsed or refractory (R/R) marginal zone lymphoma (MZL) who have ...

Core Points - BMS's Breyanzi has been approved by the U.S. FDA as the first and only CAR T cell therapy specifically for adults with relapsed or refractory marginal zone lymphoma (MZL) [1] Company Summary - The approval of Breyanzi represents a significant advancement in the treatment options available for patients suffering from MZL, a type of non-Hodgkin lymphoma [1] - This approval may enhance BMS's position in the oncology market, particularly in the CAR T cell therapy segment [1] Industry Summary - The approval of Breyanzi could lead to increased competition in the CAR T cell therapy market, as it sets a precedent for future therapies targeting specific lymphoma types [1] - The development of targeted therapies like Breyanzi reflects a growing trend in the pharmaceutical industry towards personalized medicine [1]

Core Insights - The ADEPT-2 study will continue with the enrollment of additional patients following the identification of irregularities during clinical trial site reviews [1] - The company reported the irregularities to the data monitoring committee and the FDA, leading to the exclusion of certain sites and patients from the study [1] - An agreement was reached with the FDA and the DMC to conduct an interim analysis of the study [2]

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]

Financial Data and Key Metrics Changes - The company reported a strong year in 2025, with over 50% of the business transitioning to a growth portfolio that grew by 18% in the most recent quarter [23] - The growth portfolio now includes four products that are annualizing over $1 billion, with Reblozyl annualizing over $2 billion [23][24] - The company achieved a reduction in its expense base from $17.8 billion last year to $16.5 billion this year, with a target of an additional $1 billion in savings for 2026 and 2027 [26][27] Business Line Data and Key Metrics Changes - Cobenfy, a product for schizophrenia, has surpassed 2,700 TRXs weekly and is approaching 3,000 TRXs, significantly exceeding other recent schizophrenia launches [10][11] - Camzyos is annualizing over $1 billion, with expectations for continued significant growth as awareness and diagnosis rates improve [76] - The company is focusing on expanding its pipeline with multiple studies in areas such as Alzheimer's disease, bipolar disorder, and autism irritability [17][21] Market Data and Key Metrics Changes - The company has established a strong access position in Medicaid, Medicare, and commercial settings for Cobenfy, which is critical given the dominance of government payers in this space [10] - The launch of Cuvantic has seen a strong conversion from IV to subcutaneous administration, with expectations that 30%-40% of the IV business will convert by 2028 [44] Company Strategy and Development Direction - The company aims to continue driving its growth portfolio and executing against its pipeline, with a focus on operational efficiencies and cash flow generation [25][27] - The company is leveraging AI to enhance efficiency in drug development and manufacturing processes, which is expected to drive shareholder value [29][30] - The company is actively seeking partnerships and acquisitions in therapeutic areas with high unmet needs, particularly in immunology and oncology [39][40] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth trajectory and operational efficiencies, with a strong cash position of $17 billion at the end of Q3 [28] - The company is optimistic about upcoming data readouts and the potential for new product launches, particularly in the areas of atrial fibrillation and Alzheimer's disease [66][70] Other Important Information - The company is engaging with policymakers on tariff and healthcare policy issues, emphasizing the importance of access to medicines and the normalization of cost differentials [94][95] - The company has implemented direct-to-patient initiatives, significantly reducing costs for patients, which aligns with broader industry trends [97][98] Q&A Session Summary Question: Can you discuss the recent developments in the COVID study? - The company announced that the ADEPT 2 study will continue with additional patient enrollment after addressing irregularities found during clinical trial site reviews [5][6] Question: What is the current status of Cobenfy in the market? - Cobenfy has achieved strong access in Medicaid, Medicare, and commercial settings, with TRXs approaching 3,000 weekly, indicating significant market traction [10][11] Question: How is the company leveraging AI for efficiencies? - AI is being used to enhance drug development processes, improve manufacturing efficiency, and streamline internal operations, which is expected to drive shareholder value [29][30] Question: What are the company's plans for future product development? - The company has multiple studies underway in various therapeutic areas, including Alzheimer's disease and bipolar disorder, and is confident in the potential for positive outcomes [17][21] Question: How is the company addressing the competitive landscape in oncology? - The company is focusing on partnerships and acquisitions in areas with high unmet needs, particularly in immunology and oncology, to strengthen its market position [39][40]

Financial Data and Key Metrics Changes - The company reported a strong year in 2025, with the growth portfolio now comprising over 50% of the business and growing at 18% [30] - The growth portfolio includes four products annualizing over $1 billion, with Reblozyl exceeding $2 billion [31] - The company achieved a reduction in expense base from $17.8 billion last year to $16.5 billion this year, with an additional $1 billion in savings expected for 2026 and 2027 [33] Business Line Data and Key Metrics Changes - Cobenfy has surpassed 2,700 TRXs weekly, approaching 3,000 TRXs, significantly exceeding other recent schizophrenia launches [12] - Camzyos is annualizing over $1 billion, with expectations for continued significant growth as awareness and diagnosis rates improve [87] - The Cuvantic launch has seen strong conversion from IV to subcutaneous administration, with expectations of 30%-40% conversion of IV business by 2028 [51] Market Data and Key Metrics Changes - The company has a strong access position in Medicaid, Medicare, and commercial settings, which is critical in the schizophrenia market [12] - The company is seeing broad utility across various tumor types for Cuvantic, indicating a strong market presence [50] - The company is actively pursuing opportunities in China, recognizing the increasing percentage of INDs coming from that region [75] Company Strategy and Development Direction - The focus for 2026 is to continue driving the growth portfolio and executing against the pipeline, with a strong emphasis on operational efficiencies [32] - The company is leveraging AI to enhance drug development processes and improve operational efficiencies [35] - The company is committed to exploring high unmet needs in therapeutic areas where they have scientific expertise and commercial acumen [42] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ADEPT program and the broader Cobenfy development program, projecting positive outcomes from ongoing studies [7] - The company is optimistic about the upcoming phase 3 data readouts and the potential for new NMEs by the end of the decade [32] - Management highlighted the importance of direct-to-patient initiatives to improve access and affordability of medications [114] Other Important Information - The company is actively engaging with policymakers regarding tariffs and supply chain flexibility, emphasizing the importance of access to medicines [108] - The company has made significant investments in AI to enhance efficiency in drug development and manufacturing processes [35] - The company is exploring partnerships and acquisitions in areas with high unmet medical needs, particularly in immunology and oncology [45] Q&A Session Summary Question: What is the outlook for the ADEPT studies? - Management is confident in the ADEPT program and has already initiated studies in various indications, including Alzheimer's and bipolar disorder [22][24] Question: How is the company leveraging AI for efficiencies? - AI is being used to accelerate drug development, improve site selection, and enhance manufacturing processes, driving overall efficiency [35][36] Question: What is the strategy for capital deployment moving forward? - The company will continue to focus on high unmet needs within existing therapeutic areas while also exploring new opportunities for partnerships and acquisitions [42][45] Question: How is the Cuvantic launch performing? - The Cuvantic launch has seen strong conversion rates and broad utility across multiple tumor types, with expectations for continued growth [50][51] Question: What are the expectations for Camzyos? - Camzyos is expected to see significant growth as awareness and diagnosis rates improve, with a focus on expanding its use in community cardiology [87][90]

Core Viewpoint - Bristol Myers' stock experienced a rally as investors remain optimistic about Cobenfy as a potential Alzheimer's treatment, despite a delay in the outcome of a late-stage trial [1] Group 1 - Investors are maintaining high hopes for Cobenfy, indicating strong market interest and potential for future growth in the Alzheimer's treatment sector [1] - The delay in the late-stage trial outcome has not significantly dampened investor sentiment, suggesting confidence in the drug's prospects [1]

Core Viewpoint - Bristol Myers Squibb (BMY) is expanding patient enrollment in the ADEPT-2 Phase 3 study for Cobenfy, a drug aimed at treating psychosis associated with Alzheimer's disease dementia, following a recommendation from the Data Monitoring Committee (DMC) after an interim analysis [1][6]. Study Details - The ADEPT-2 study is a multicenter, randomized, double-blind, placebo-controlled trial focused on assessing the safety and efficacy of Cobenfy in patients with Alzheimer's-related psychosis [2]. - The primary endpoint of the study is the change in the Neuropsychiatric Inventory-Clinician (NPI-C): Hallucinations and Delusions (H+D) score, while the key secondary endpoint is the Clinical Global Impression-Severity (CGI-S) [3]. Clinical Trial Adjustments - Irregularities were identified in the clinical trial execution at a few study sites, leading the company to exclude data from these sites from the primary analysis after consulting with the FDA [4][5]. - The DMC recommended continuing the study with additional patient enrollment, and Bristol Myers will proceed as advised while remaining blinded to the study data [6]. Market Reaction and Analyst Insights - Analysts view the ADEPT-2 study as crucial due to the significant market opportunity and the need for positive momentum following recent setbacks in other late-stage programs [7]. - The backing from the DMC and FDA for continued enrollment is seen as a potentially positive signal, especially given the pressure on Bristol Myers shares [7][8]. - Additional results from the ADEPT program, including ADEPT-1 and ADEPT-4, are expected to be released by the end of 2026, which is later than previously anticipated [8]. Stock Performance - Bristol Myers Squibb shares experienced a 5.77% increase, reaching $51.03 at the time of publication [10].

Core Insights - Terray has achieved a significant milestone in its collaboration with Bristol Myers Squibb, indicating progress in their joint efforts in the biotech sector [1] Company Summary - The collaboration between Terray and Bristol Myers Squibb focuses on advancing drug discovery and development processes, leveraging Terray's innovative technology [1] - This milestone reflects the ongoing commitment of both companies to enhance therapeutic options in the market [1] Industry Summary - The biotech industry continues to see strategic partnerships as a key driver for innovation and efficiency in drug development [1] - Collaborations like that of Terray and Bristol Myers Squibb are essential for accelerating the pace of bringing new therapies to patients [1]

Core Viewpoint - Bristol-Myers Squibb (BMY.US) shares rose by 5% to $50.67 following the announcement of increased participant recruitment for a late-stage trial assessing the safety and efficacy of Cobenfy for Alzheimer's disease-related psychosis [1] Group 1: Company Developments - Bristol-Myers Squibb announced plans to recruit more participants for a late-stage trial of Cobenfy, aimed at evaluating its safety and efficacy in treating Alzheimer's disease-related psychosis [1] - The decision to increase recruitment was made after identifying "non-compliance" issues at a few trial sites related to clinical study execution, leading to the exclusion of patient data from the primary analysis [1] Group 2: Product Information - Cobenfy is currently approved for the treatment of adult schizophrenia and has the potential to become the first drug therapy based on muscarinic receptor agonism targeting agitation and psychosis [1] - Results from the ADEPT program, which includes ADEPT-2, ADEPT-1, and ADEPT-4 trials for Alzheimer's disease-related psychosis, are expected to be revealed by the end of 2026 [1]