Bristol Myers Squibb's Iberdomide Application Receives FDA Priority Review
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Feb 17 2026
0mins
Should l Buy BMY?
Source: seekingalpha
- FDA Priority Review: Bristol Myers Squibb announced that its marketing application for iberdomide, an experimental therapy for multiple myeloma, has received priority review from the FDA, marking a significant advancement in the blood cancer treatment landscape.
- Target Action Date: The FDA has set August 17, 2026, as the target action date for the New Drug Application, a timeline that will directly influence the company's future market strategy and financial performance.
- Clinical Trial Support: The application is backed by data from the ongoing Phase 3 EXCALIBER-RRMM study, aimed at providing new treatment options for patients with relapsed or refractory multiple myeloma, demonstrating the company's continued investment in research and development.
- Disease Response Evaluation: The application focuses on the endpoint related to minimal residual disease (MRD), which has become a critical measure for evaluating treatment response in multiple myeloma, reflecting the company's commitment to clinical efficacy and its competitive positioning in the market.
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Analyst Views on BMY
Wall Street analysts forecast BMY stock price to fall
20 Analyst Rating
8 Buy
11 Hold
1 Sell
Moderate Buy
Current: 61.300
Low
37.00
Averages
55.86
High
68.00
Current: 61.300
Low
37.00
Averages
55.86
High
68.00
About BMY
Bristol-Myers Squibb Company is a global biopharmaceutical company. It is engaged in the discovery, development and delivery of transformational medicines for patients facing serious diseases in areas: oncology, hematology, immunology, cardiovascular, neuroscience and other areas. Its growth portfolio includes Opdivo (nivolumab), Opdivo Qvantig (nivolumab and hyaluronidase-nvhy), Yervoy (ipilimumab), Reblozyl (luspatercept-aamt), Opdualag (nivolumab and relatlimab-rmbw), Breyanzi (lisocabtagene maraleucel), Camzyos (mavacamten), Zeposia (ozanimod), Abecma (idecabtagene vicleucel), and Sotyktu (deucravacitinib). Its other growth products include Onureg, Inrebic, and Empliciti. Its legacy portfolio includes Eliquis (apixaban), Revlimid (lenalidomide), Pomalyst/Imnovid (pomalidomide), Sprycel (dasatinib), and Abraxane (paclitaxel albumin-bound particles for injectable suspension). Opdivo (nivolumab) is a fully human monoclonal antibody that binds to the PD-1 on T and NKT cells.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Bristol Myers Squibb Reports Positive Phase 3 Trial Results
- Clinical Trial Results: Bristol Myers Squibb's collaboration with SystImmune on izalontamab brengitecan (Iza-bren) achieved dual primary endpoints of progression-free survival and overall survival in its Phase 3 trial, highlighting its potential in treating advanced triple-negative breast cancer and possibly opening new treatment avenues for patients.
- Market Reaction: Despite mixed overall market performance with the Nasdaq slightly down, Bristol Myers Squibb shares fell 0.56% to $60.95 following the positive trial results, indicating a cautious market sentiment towards the stock in the short term.
- Technical Analysis: The stock is currently trading 4.1% below its 20-day simple moving average and 9.8% below its 100-day moving average, suggesting some short-term weakness, with an RSI of 44.45 indicating a neutral position and a MACD of 0.15 below its signal line of 0.22, reflecting bearish pressure on the stock.
- Analyst Ratings: The stock carries an average price target of $60.09 with a Hold rating, while RBC Capital and Barclays set targets at $75.00, and Piper Sandler raised its target to $75.00, indicating varying market expectations for the stock's future performance.
See More
Bristol Myers Squibb's Antibody Drug Achieves Success in China Trial
- Clinical Trial Success: Bristol Myers Squibb and partner SystImmune's antibody-drug conjugate, izalontamab brengitecan, successfully met dual primary endpoints of progression-free survival and overall survival in a Phase 3 trial for triple-negative breast cancer in China, marking a significant breakthrough in treatment options.
- Historic Milestone: This trial result represents the third late-stage success for izalontamab brengitecan and the first bispecific ADC to achieve dual positive data in triple-negative breast cancer, highlighting its potential and innovation in oncology.
- Future Outlook: The BL-B01D1-307 study, sponsored by SystImmune's parent company Sichuan Biokin Pharmaceutical Co., Ltd., is expected to present results at an upcoming medical event, further advancing the drug's clinical application and market recognition.
- Strategic Partnership: In 2023, Bristol Myers Squibb signed a licensing deal worth up to $8.4 billion to develop izalontamab brengitecan outside of China, demonstrating the company's confidence in the drug's global market potential.
See More
Bristol-Myers Squibb Rated Among 14 Best Affordable Dividend Stocks
- Analyst Rating: On February 25, RBC Capital initiated coverage of Bristol-Myers Squibb (BMY) with a Sector Perform rating and a $60 price target, highlighting its significant Phase 3 pipeline depth among large-cap pharma companies.
- Macro Factors Impact: The analyst noted that the recent re-rating of BMY shares is primarily tied to broader macroeconomic factors, valuation shifts, and positioning ahead of potential catalysts in the second half of 2026, rather than a major change in the company's fundamentals, suggesting a balanced risk-reward scenario.
- Clinical Trial Progress: On February 23, Bristol-Myers announced positive top-line results from its Phase 2 registrational study evaluating Reblozyl for anemia in adults with Alpha-Thalassemia, showing significant increases in hemoglobin levels in non-transfusion-dependent patients and reductions in transfusion needs for transfusion-dependent patients.
- Safety Results: The study also met all key secondary endpoints, with safety results consistent with Reblozyl's established safety profile in treating thalassemia, further reinforcing its potential application in this therapeutic area.
See More
RBC Initiates Coverage of Bristol Myers Squibb with Sector Perform Rating
- Coverage Initiation: RBC Capital Markets has initiated coverage of Bristol Myers Squibb (BMY) with a sector perform rating, indicating that while the company has a solid late-stage pipeline, the risk/reward profile is balanced at current levels.
- Price Target Set: The bank has set a price target of $60, which implies approximately 3% downside based on the February 24 close, reflecting a cautious market outlook on the company's future performance.
- Pipeline Potential: Analyst Trung Huynh noted that Bristol has the most significant Phase 3 paths among large-cap pharma, including milvexian (stroke/AF) and Cobenfy (Alzheimer's psychosis), highlighting its research and development potential.
- Revenue Decline Forecast: Huynh projects that Bristol's revenues will decline from $48 billion in 2025 to $31 billion in 2034, primarily due to around $30 billion in product loss of exclusivity by 2030, emphasizing the need for pipeline approvals to offset this loss.
See More
Overview of FDA Regulatory Developments
- BHA Safety Reassessment: On February 10, 2026, the FDA initiated a comprehensive reassessment of Butylated Hydroxyanisole (BHA) to evaluate its safety in food and food contact substances based on the latest scientific data, despite its classification as a potential human carcinogen in animal studies, which could affect consumer confidence in food safety.
- Hormone Therapy Labeling Updates: On February 12, 2026, the FDA approved labeling updates for six menopausal hormone therapy products, including Prometrium and Divigel, clarifying risk considerations and removing boxed warnings related to cardiovascular disease, breast cancer, and probable dementia, which may enhance market acceptance of these therapies.
- Innovative Device Approval: On the same day, the FDA approved Novocure's Optune Pax, a first-of-its-kind device for treating locally advanced pancreatic cancer, marking a significant technological advancement in cancer treatment and potentially providing new options for patients.
- Biotech Stocks Under Scrutiny: With upcoming FDA decisions in March 2026, biotech stocks are under market scrutiny, and investors should closely monitor the potential impacts of these decisions on related companies, which could trigger market volatility.
See More
Mental Health Treatment Market Set for Accelerated Growth
- Surging Market Demand: With over 970 million people affected by mental health disorders globally, the mental health therapeutics market is projected to exceed $40 billion in the coming years, indicating a strong demand for new treatment options, particularly in depression and anxiety.
- Clinical Milestone: Helus Pharma has appointed former Pfizer Chief Medical Officer Dr. Freda Lewis-Hall to its Board and as Chair of the Scientific Advisory Committee, leveraging her 40 years of experience to enhance the company's clinical development and regulatory strategy in the mental health sector.
- Innovative Drug Prospects: Compass Pathways' COMP360 has shown significant results in clinical trials for treatment-resistant depression, demonstrating efficacy in symptom reduction, which is expected to propel the company's further development in the mental health treatment market.
- Strategic Investment Opportunities: As large pharmaceutical companies seek to refresh their CNS drug pipelines, NSAs are viewed as a high-impact category with expansion potential, attracting investor attention towards clinical milestones and commercialization signals, indicating strong future returns.
See More
Bristol Myers Squibb Reports Positive Phase 3 Trial Results
- Clinical Trial Results: Bristol Myers Squibb's collaboration with SystImmune on izalontamab brengitecan (Iza-bren) achieved dual primary endpoints of progression-free survival and overall survival in its Phase 3 trial, highlighting its potential in treating advanced triple-negative breast cancer and possibly opening new treatment avenues for patients.
- Market Reaction: Despite mixed overall market performance with the Nasdaq slightly down, Bristol Myers Squibb shares fell 0.56% to $60.95 following the positive trial results, indicating a cautious market sentiment towards the stock in the short term.
- Technical Analysis: The stock is currently trading 4.1% below its 20-day simple moving average and 9.8% below its 100-day moving average, suggesting some short-term weakness, with an RSI of 44.45 indicating a neutral position and a MACD of 0.15 below its signal line of 0.22, reflecting bearish pressure on the stock.
- Analyst Ratings: The stock carries an average price target of $60.09 with a Hold rating, while RBC Capital and Barclays set targets at $75.00, and Piper Sandler raised its target to $75.00, indicating varying market expectations for the stock's future performance.
See More
Bristol Myers Squibb's Antibody Drug Achieves Success in China Trial
- Clinical Trial Success: Bristol Myers Squibb and partner SystImmune's antibody-drug conjugate, izalontamab brengitecan, successfully met dual primary endpoints of progression-free survival and overall survival in a Phase 3 trial for triple-negative breast cancer in China, marking a significant breakthrough in treatment options.
- Historic Milestone: This trial result represents the third late-stage success for izalontamab brengitecan and the first bispecific ADC to achieve dual positive data in triple-negative breast cancer, highlighting its potential and innovation in oncology.
- Future Outlook: The BL-B01D1-307 study, sponsored by SystImmune's parent company Sichuan Biokin Pharmaceutical Co., Ltd., is expected to present results at an upcoming medical event, further advancing the drug's clinical application and market recognition.
- Strategic Partnership: In 2023, Bristol Myers Squibb signed a licensing deal worth up to $8.4 billion to develop izalontamab brengitecan outside of China, demonstrating the company's confidence in the drug's global market potential.
See More
Bristol-Myers Squibb Rated Among 14 Best Affordable Dividend Stocks
- Analyst Rating: On February 25, RBC Capital initiated coverage of Bristol-Myers Squibb (BMY) with a Sector Perform rating and a $60 price target, highlighting its significant Phase 3 pipeline depth among large-cap pharma companies.
- Macro Factors Impact: The analyst noted that the recent re-rating of BMY shares is primarily tied to broader macroeconomic factors, valuation shifts, and positioning ahead of potential catalysts in the second half of 2026, rather than a major change in the company's fundamentals, suggesting a balanced risk-reward scenario.
- Clinical Trial Progress: On February 23, Bristol-Myers announced positive top-line results from its Phase 2 registrational study evaluating Reblozyl for anemia in adults with Alpha-Thalassemia, showing significant increases in hemoglobin levels in non-transfusion-dependent patients and reductions in transfusion needs for transfusion-dependent patients.
- Safety Results: The study also met all key secondary endpoints, with safety results consistent with Reblozyl's established safety profile in treating thalassemia, further reinforcing its potential application in this therapeutic area.
See More
RBC Initiates Coverage of Bristol Myers Squibb with Sector Perform Rating
- Coverage Initiation: RBC Capital Markets has initiated coverage of Bristol Myers Squibb (BMY) with a sector perform rating, indicating that while the company has a solid late-stage pipeline, the risk/reward profile is balanced at current levels.
- Price Target Set: The bank has set a price target of $60, which implies approximately 3% downside based on the February 24 close, reflecting a cautious market outlook on the company's future performance.
- Pipeline Potential: Analyst Trung Huynh noted that Bristol has the most significant Phase 3 paths among large-cap pharma, including milvexian (stroke/AF) and Cobenfy (Alzheimer's psychosis), highlighting its research and development potential.
- Revenue Decline Forecast: Huynh projects that Bristol's revenues will decline from $48 billion in 2025 to $31 billion in 2034, primarily due to around $30 billion in product loss of exclusivity by 2030, emphasizing the need for pipeline approvals to offset this loss.
See More
Overview of FDA Regulatory Developments
- BHA Safety Reassessment: On February 10, 2026, the FDA initiated a comprehensive reassessment of Butylated Hydroxyanisole (BHA) to evaluate its safety in food and food contact substances based on the latest scientific data, despite its classification as a potential human carcinogen in animal studies, which could affect consumer confidence in food safety.
- Hormone Therapy Labeling Updates: On February 12, 2026, the FDA approved labeling updates for six menopausal hormone therapy products, including Prometrium and Divigel, clarifying risk considerations and removing boxed warnings related to cardiovascular disease, breast cancer, and probable dementia, which may enhance market acceptance of these therapies.
- Innovative Device Approval: On the same day, the FDA approved Novocure's Optune Pax, a first-of-its-kind device for treating locally advanced pancreatic cancer, marking a significant technological advancement in cancer treatment and potentially providing new options for patients.
- Biotech Stocks Under Scrutiny: With upcoming FDA decisions in March 2026, biotech stocks are under market scrutiny, and investors should closely monitor the potential impacts of these decisions on related companies, which could trigger market volatility.
See More
Mental Health Treatment Market Set for Accelerated Growth
- Surging Market Demand: With over 970 million people affected by mental health disorders globally, the mental health therapeutics market is projected to exceed $40 billion in the coming years, indicating a strong demand for new treatment options, particularly in depression and anxiety.
- Clinical Milestone: Helus Pharma has appointed former Pfizer Chief Medical Officer Dr. Freda Lewis-Hall to its Board and as Chair of the Scientific Advisory Committee, leveraging her 40 years of experience to enhance the company's clinical development and regulatory strategy in the mental health sector.
- Innovative Drug Prospects: Compass Pathways' COMP360 has shown significant results in clinical trials for treatment-resistant depression, demonstrating efficacy in symptom reduction, which is expected to propel the company's further development in the mental health treatment market.
- Strategic Investment Opportunities: As large pharmaceutical companies seek to refresh their CNS drug pipelines, NSAs are viewed as a high-impact category with expansion potential, attracting investor attention towards clinical milestones and commercialization signals, indicating strong future returns.
See More
