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: 57.540
Low
37.00
Averages
55.86
High
68.00
Current: 57.540
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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- Drug Mechanism: As a CDK9 inhibitor, SLS009 aims to block cancer cell survival and growth, with the current trial evaluating its efficacy in relapsed or refractory AML patients, potentially providing new treatment options in a competitive market.
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- Bristol Myers' Recovery: After facing patent cliffs, Bristol Myers' revenue is slowly rebounding, and while it faces more patent expirations, the approval of a new subcutaneous version of Opdivo is expected to contribute to revenue growth in the coming years.
- Collaboration and Innovation: Bristol Myers is partnering with Johnson & Johnson to develop the next-gen anticoagulant Milvexian, which has received FDA Fast Track designation, indicating strong market potential, while also working on bispecific antibodies, with significant progress expected in the coming years.
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- Medtronic's Growth Potential: Medtronic has raised its dividend for 49 years, with a current yield of 3.43%, and is expected to achieve 5%-6% annualized earnings growth, while its newly launched Hugo system may provide additional growth in the robotics-assisted surgery sector.
- Bristol Myers Squibb's Risks and Opportunities: Bristol Myers Squibb offers a 4.3% dividend yield but faces risks from patent expirations that could impact revenue; however, its development pipeline aims to introduce 10 new drugs in the coming years, presenting growth potential.
- Industry Outlook Analysis: The healthcare sector is projected to reach $5.7 trillion in spending by 2025, and while high-yield stocks carry risks, the stable market demand and innovation in pharmaceuticals make long-term investments appealing.
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- Market Competitive Edge: This study is the only global head-to-head trial comparing KRAS G12C inhibitors, with Divarasib showing superior treatment potential against Amgen's Lumakras and BMY's Krazati, which may enhance Roche's competitive position in the lung cancer market.
- FDA Breakthrough Therapy Designation: Divarasib received Breakthrough Therapy Designation from the FDA in 2022, which is expected to expedite its approval process, addressing the urgent treatment needs of patients with KRAS G12C mutations and filling a significant market gap.
- Strategic Collaboration Expansion: Roche entered into an exclusive licensing agreement with Nurix Therapeutics to co-develop and commercialize bexobrutideg, which is expected to provide new growth opportunities for Roche's hematology pipeline while strengthening its presence in immunology and neurology.
See More
