Bristol-Myers Squibb Co. Receives Breakthrough Therapy Designation and Priority Review from U.S. FDA, with Target Action Date Set for August 17, 2026
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 1 day ago
0mins
Should l Buy BMY?
Source: moomoo
- Target Action Date: The U.S. FDA has set a target action date of August 17, 2026, for the grants related to the therapy designation and priority review.
- Grants Overview: The announcement pertains to grants that are expected to facilitate advancements in therapeutic designations and priority reviews.
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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: 60.350
Low
37.00
Averages
55.86
High
68.00
Current: 60.350
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 Co. Receives Breakthrough Therapy Designation and Priority Review from U.S. FDA, with Target Action Date Set for August 17, 2026
- Target Action Date: The U.S. FDA has set a target action date of August 17, 2026, for the grants related to the therapy designation and priority review.
- Grants Overview: The announcement pertains to grants that are expected to facilitate advancements in therapeutic designations and priority reviews.
See More
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- Collaborative Drug Development: AstraZeneca and Bristol Myers Squibb are partnering with Switzerland-based Evinova to leverage its AI-native platform for drug development, aiming to enhance research efficiency and reduce costs.
- Cost Savings in R&D: Evinova claims its platform can deliver at least 5%-7% savings per study, which will significantly improve the economic viability of drug development and enhance the competitive edge of the partners in the market.
- Intelligent Clinical Design: Evinova's AI digitizer capability converts clinical study designs, protocols, and documents into machine-readable formats, improving data processing efficiency and accelerating the drug development timeline.
- Multi-Partner Collaboration Model: The platform's flexible architecture enables a multi-model partner approach, providing access to advanced AI models and deep enterprise expertise, fostering smarter operational insights and driving innovation in the industry.
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- Market Size Growth: According to DelveInsight's analysis, the juvenile idiopathic arthritis market is projected to reach USD 2.3 billion by 2025, indicating stable growth potential over the next decade, reflecting increasing demand for new therapies.
- Increased Disease Awareness: As awareness of juvenile idiopathic arthritis rises, the total cases in the 7MM are expected to increase from 141,800 in 2025 to 173,000 by 2036, with a CAGR of 1.8%, driving demand for new treatment options.
- Emerging Therapies Launch: Emerging therapies such as SOTYKTU from Bristol-Myers Squibb and BIMZELX from UCB Biopharma are in clinical trials and are expected to transform the market landscape by providing more effective treatment options, thereby enhancing patient quality of life.
- Intensifying Market Competition: With multiple pharmaceutical companies like Novartis and AbbVie entering the juvenile idiopathic arthritis treatment space, competition will intensify, driving innovation and R&D investment, further accelerating rapid market development.
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- 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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Bristol-Myers Squibb Co. Receives Breakthrough Therapy Designation and Priority Review from U.S. FDA, with Target Action Date Set for August 17, 2026
- Target Action Date: The U.S. FDA has set a target action date of August 17, 2026, for the grants related to the therapy designation and priority review.
- Grants Overview: The announcement pertains to grants that are expected to facilitate advancements in therapeutic designations and priority reviews.
See More
AstraZeneca and Bristol Myers Squibb Collaborate with Evinova for AI Drug Development
- Collaborative Drug Development: AstraZeneca and Bristol Myers Squibb are partnering with Switzerland-based Evinova to leverage its AI-native platform for drug development, aiming to enhance research efficiency and reduce costs.
- Cost Savings in R&D: Evinova claims its platform can deliver at least 5%-7% savings per study, which will significantly improve the economic viability of drug development and enhance the competitive edge of the partners in the market.
- Intelligent Clinical Design: Evinova's AI digitizer capability converts clinical study designs, protocols, and documents into machine-readable formats, improving data processing efficiency and accelerating the drug development timeline.
- Multi-Partner Collaboration Model: The platform's flexible architecture enables a multi-model partner approach, providing access to advanced AI models and deep enterprise expertise, fostering smarter operational insights and driving innovation in the industry.
See More
Analysis of Growth in Juvenile Idiopathic Arthritis Market
- Market Size Growth: According to DelveInsight's analysis, the juvenile idiopathic arthritis market is projected to reach USD 2.3 billion by 2025, indicating stable growth potential over the next decade, reflecting increasing demand for new therapies.
- Increased Disease Awareness: As awareness of juvenile idiopathic arthritis rises, the total cases in the 7MM are expected to increase from 141,800 in 2025 to 173,000 by 2036, with a CAGR of 1.8%, driving demand for new treatment options.
- Emerging Therapies Launch: Emerging therapies such as SOTYKTU from Bristol-Myers Squibb and BIMZELX from UCB Biopharma are in clinical trials and are expected to transform the market landscape by providing more effective treatment options, thereby enhancing patient quality of life.
- Intensifying Market Competition: With multiple pharmaceutical companies like Novartis and AbbVie entering the juvenile idiopathic arthritis treatment space, competition will intensify, driving innovation and R&D investment, further accelerating rapid market development.
See More
Bristol Myers Squibb's Iberdomide Application Receives FDA Priority Review
- 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.
See More
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- Investment Stake Reduction: Mubadala Investment Company has cut its share stake in Arm Holdings by 8.3%, reducing its ownership to 1.4 million shares.
- Sponsored Ads Impact: The reduction in stake is highlighted in a recent SEC filing, indicating potential implications for sponsored ads and investment strategies.
See More
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- Regulatory Filing: The reduction in shares was disclosed in a recent SEC filing.
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