Bristol-Myers Squibb's Opdivo Receives FDA Priority Review
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Feb 21 2024
0mins
Source: NASDAQ.COM
Bristol-Myers Squibb Co (BMY) saw a price increase of 3.01%, reaching a 20-day high, despite the Nasdaq-100 and S&P 500 experiencing declines of 0.51% and 0.24%, respectively.
This surge is attributed to the FDA granting priority review for Bristol-Myers Squibb's Opdivo for Hodgkin lymphoma, marking a significant milestone in treatment options for patients. The acceptance of the supplemental Biologics License Application is based on promising clinical trial data, which indicates the potential for improved patient outcomes and solidifies the company's position in oncology.
The FDA's decision is expected to enhance investor confidence and may lead to increased market interest in Bristol-Myers Squibb's innovative therapies, particularly as the company continues to advance its pipeline in oncology and immunotherapy.
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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: 56.910
Low
37.00
Averages
55.86
High
68.00
Current: 56.910
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), Orencia (abatacept), Yervoy (ipilimumab), Reblozyl (luspatercept-aamt), Breyanzi (lisocabtagene maraleucel), Opdualag (nivolumab and relatlimab-rmbw), Camzyos (mavacamten), Zeposia (ozanimod), Abecma (idecabtagene vicleucel), Sotyktu (deucravacitinib), Krazati (adagrasib), and Cobenfy (xanomeline and trospium chloride). Its other growth products include Augtyro, Onureg, Inrebic, Nulojix, and Empliciti. Its legacy portfolio includes Eliquis (apixaban), Revlimid (lenalidomide), Pomalyst/Imnovid (pomalidomide), Sprycel (dasatinib), and Abraxane (paclitaxel albumin-bound particles for injectable suspension).
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.
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- Strong Market Reaction: Following BMY's announcement, C4 Therapeutics' stock surged to a 52-week high, indicating increased investor confidence in its lead candidate cemsidomide, particularly given the similarities in treatment strategies.
- Future Data Sharing Plans: C4 plans to present data from a Phase 1b trial evaluating cemsidomide in combination with approved multiple myeloma therapies in H2 2026, which will further support its market prospects.
- Analyst Optimism: Jefferies analyst Akash Tewari expressed a positive outlook for C4, suggesting that BMY's favorable data will have a beneficial read-through for C4, maintaining a Buy rating on the stock, reflecting market recognition of its growth potential.
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- Patient Data Analysis: In the open-label Phase 3 SUCCESSOR-2 trial, 479 patients were enrolled, and the mezigdomide-containing regimen reduced the risk of disease progression or death by 52% compared to the standard treatment.
- Safety Assessment: While mezigdomide showed a safety profile consistent with past data, 83.7% of patients experienced Grade 3 or 4 treatment-emergent adverse events, compared to 56.5% in the comparator arm, indicating a higher incidence of side effects.
- Future Outlook: Data from the SUCCESSOR-2 trial will be presented at the ASCO 2026 meeting and is set to be submitted to health regulators, further enhancing the market potential of this therapy.
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- Reliance on International Collaboration: JW Therapeutics continues to thrive in cross-border collaborations, particularly in cell and gene therapies, with Tian emphasizing that the company has not felt any impact from regulatory changes, showcasing its stability and adaptability in the international market.
- Investor Confidence Challenges: While JW Therapeutics operates normally, China's blocking of Meta's acquisition of Manus may heighten risks for global investors looking to invest in advanced tech firms with ties to the country, potentially affecting future investment decisions.
- Exploring Cooperation Opportunities: JW is actively seeking collaborations with companies outside China, particularly within its product pipeline, reflecting the company's strategic intent to expand in the global market.
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- Patent Cliff Risk: Bristol Myers Squibb faces a daunting patent cliff, with sales of its blood cancer drug Revlimid sharply declining due to generic competition, while its top-selling drugs Eliquis and Opdivo will lose U.S. patent exclusivity in 2028, potentially leading to significant future revenue declines.
- Acquisition Integration Challenges: The company acquired Mirati Therapeutics, Karuna Therapeutics, and RayzeBio in 2023, and while these acquisitions may enhance growth prospects, they also introduce integration and clinical risks that could impact short-term financial performance.
- Growth vs. Legacy Drug Conflict: Although Bristol Myers Squibb emphasized in its 2026 Q1 earnings report that its growth portfolio constitutes the majority of total revenue, legacy drugs still account for approximately 46% of revenue, and with total revenue increasing by only 1% on a constant-currency basis, there is a risk that new drugs may not offset losses from older blockbusters.
- Investor Risk Appetite: For risk-averse investors, Bristol Myers Squibb may not be an ideal choice, while patient long-term investors might find the 4.2% dividend yield appealing, indicating that the stock could still be attractive under certain investment styles.
See More
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- Patent Cliff Risks: Bristol Myers Squibb's blood cancer drug Revlimid is experiencing a sharp decline in sales due to generic competition, and its two top-selling products, Eliquis and Opdivo, are set to lose U.S. patent exclusivity by 2028, posing significant revenue challenges ahead.
- Limited Growth Potential: Although the company has made acquisitions of Mirati Therapeutics, Karuna Therapeutics, and RayzeBio in 2023 to enhance growth prospects, its legacy drugs still account for approximately 46% of total revenue, with overall revenue growth stagnating at just 1%, indicating that new drugs may not offset losses from older blockbusters.
- Diverging Investor Sentiment: Risk-averse investors may find Bristol Myers Squibb's stock unattractive, while patient investors could be drawn to its 4.2% dividend yield, despite the company's fortunes not expected to improve significantly in the short term.
- Poor Market Performance: Despite a rebound of about 11% after a decline, Bristol Myers Squibb's shares remain below their early March peak, with a forward P/E ratio of only 9.4 suggesting potential undervaluation, but investors should remain cautious of integration and clinical risks.
See More
C4 Therapeutics Hits 52-Week High Following BMY's Positive Myeloma Trial Results
- Impressive Survival Data: Bristol-Myers Squibb's (BMY) late-stage SUCCESSOR-2 trial for its multiple myeloma candidate mezigdomide demonstrated over a 50% improvement in cancer-free survival, positively impacting C4 Therapeutics (CCCC) stock performance.
- Strong Market Reaction: Following BMY's announcement, C4 Therapeutics' stock surged to a 52-week high, indicating increased investor confidence in its lead candidate cemsidomide, particularly given the similarities in treatment strategies.
- Future Data Sharing Plans: C4 plans to present data from a Phase 1b trial evaluating cemsidomide in combination with approved multiple myeloma therapies in H2 2026, which will further support its market prospects.
- Analyst Optimism: Jefferies analyst Akash Tewari expressed a positive outlook for C4, suggesting that BMY's favorable data will have a beneficial read-through for C4, maintaining a Buy rating on the stock, reflecting market recognition of its growth potential.
See More
Bristol Myers Squibb's Antitumor Drug Trial Shows Promising Results
- Clinical Trial Success: Bristol Myers Squibb's antitumor candidate mezigdomide improved cancer-free survival by over 50% in a late-stage trial for multiple myeloma, demonstrating significant clinical and statistical relevance.
- Patient Data Analysis: In the open-label Phase 3 SUCCESSOR-2 trial, 479 patients were enrolled, and the mezigdomide-containing regimen reduced the risk of disease progression or death by 52% compared to the standard treatment.
- Safety Assessment: While mezigdomide showed a safety profile consistent with past data, 83.7% of patients experienced Grade 3 or 4 treatment-emergent adverse events, compared to 56.5% in the comparator arm, indicating a higher incidence of side effects.
- Future Outlook: Data from the SUCCESSOR-2 trial will be presented at the ASCO 2026 meeting and is set to be submitted to health regulators, further enhancing the market potential of this therapy.
See More
Bristol-Myers Squibb Phase 3 Trial Results
See More
China's Pharma Sector Unaffected by Regulatory Scrutiny
- Industry Growth Outlook: JW Therapeutics CEO Leo Tian stated that despite Beijing's tightening scrutiny over sensitive technology deals, China's pharmaceutical sector remains robust, with biotech licensing deals expected to reach new heights, indicating strong demand for China-developed experimental medicines.
- Reliance on International Collaboration: JW Therapeutics continues to thrive in cross-border collaborations, particularly in cell and gene therapies, with Tian emphasizing that the company has not felt any impact from regulatory changes, showcasing its stability and adaptability in the international market.
- Investor Confidence Challenges: While JW Therapeutics operates normally, China's blocking of Meta's acquisition of Manus may heighten risks for global investors looking to invest in advanced tech firms with ties to the country, potentially affecting future investment decisions.
- Exploring Cooperation Opportunities: JW is actively seeking collaborations with companies outside China, particularly within its product pipeline, reflecting the company's strategic intent to expand in the global market.
See More
Bristol Myers Squibb Shares Rebound but Risks Remain
- Patent Cliff Risk: Bristol Myers Squibb faces a daunting patent cliff, with sales of its blood cancer drug Revlimid sharply declining due to generic competition, while its top-selling drugs Eliquis and Opdivo will lose U.S. patent exclusivity in 2028, potentially leading to significant future revenue declines.
- Acquisition Integration Challenges: The company acquired Mirati Therapeutics, Karuna Therapeutics, and RayzeBio in 2023, and while these acquisitions may enhance growth prospects, they also introduce integration and clinical risks that could impact short-term financial performance.
- Growth vs. Legacy Drug Conflict: Although Bristol Myers Squibb emphasized in its 2026 Q1 earnings report that its growth portfolio constitutes the majority of total revenue, legacy drugs still account for approximately 46% of revenue, and with total revenue increasing by only 1% on a constant-currency basis, there is a risk that new drugs may not offset losses from older blockbusters.
- Investor Risk Appetite: For risk-averse investors, Bristol Myers Squibb may not be an ideal choice, while patient long-term investors might find the 4.2% dividend yield appealing, indicating that the stock could still be attractive under certain investment styles.
See More
Bristol Myers Squibb Faces Daunting Patent Cliff
- Patent Cliff Risks: Bristol Myers Squibb's blood cancer drug Revlimid is experiencing a sharp decline in sales due to generic competition, and its two top-selling products, Eliquis and Opdivo, are set to lose U.S. patent exclusivity by 2028, posing significant revenue challenges ahead.
- Limited Growth Potential: Although the company has made acquisitions of Mirati Therapeutics, Karuna Therapeutics, and RayzeBio in 2023 to enhance growth prospects, its legacy drugs still account for approximately 46% of total revenue, with overall revenue growth stagnating at just 1%, indicating that new drugs may not offset losses from older blockbusters.
- Diverging Investor Sentiment: Risk-averse investors may find Bristol Myers Squibb's stock unattractive, while patient investors could be drawn to its 4.2% dividend yield, despite the company's fortunes not expected to improve significantly in the short term.
- Poor Market Performance: Despite a rebound of about 11% after a decline, Bristol Myers Squibb's shares remain below their early March peak, with a forward P/E ratio of only 9.4 suggesting potential undervaluation, but investors should remain cautious of integration and clinical risks.
See More
