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Bristol-Myers Squibb Company (BMY) is a global biopharmaceutical leader developing innovative therapies in oncology, cardiovascular diseases, and immunology. This dedicated news hub provides investors and healthcare professionals with direct access to BMY's latest developments, including FDA approvals, clinical trial results, and strategic partnerships.
Track critical updates through curated press releases covering drug development milestones, financial earnings reports, and research collaborations. Our aggregation ensures you never miss regulatory filings, product launch announcements, or patent developments impacting BMY's market position.
Discover timely information on therapeutic advancements in immuno-oncology and hematology, plus insights into global healthcare trends affecting pharmaceutical operations. Bookmark this page for streamlined monitoring of BMY's scientific innovations and corporate announcements essential for informed analysis.
Bristol Myers Squibb (NYSE: BMY) announced that the FDA has accepted their supplemental Biologics License Application (sBLA) for Opdivo® (nivolumab) plus Yervoy® (ipilimumab) as a potential first-line treatment for unresectable hepatocellular carcinoma (HCC). The acceptance is based on results from the Phase 3 CheckMate -9DW trial, which showed improved survival compared to lenvatinib or sorafenib. The FDA assigned a target action date of April 21, 2025.
The combination demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS). The safety profile was consistent with previously reported data and manageable with established protocols. This application could potentially bring a new first-line treatment option to HCC patients, addressing an urgent need in this increasing patient population.
Bristol Myers Squibb (NYSE: BMY) announced that the European Medicines Agency (EMA) has validated its application to expand the indication for Breyanzi, a CAR T cell therapy, for treating adult patients with relapsed or refractory follicular lymphoma who have received two or more prior lines of systemic therapy. The application is based on data from the Phase 2 TRANSCEND FL study, which showed high overall response rates with deep and durable responses. Breyanzi demonstrated a consistent and manageable safety profile.
Additionally, Breyanzi received approval in Japan for treating relapsed or refractory follicular lymphoma after one prior line of systemic therapy in high-risk patients and after two or more lines of systemic therapy. This makes it the first CAR T treatment approved for this high-risk population with unmet needs.
Bristol Myers Squibb (NYSE: BMY) announced its second quarter 2024 financial results, reporting revenues of $12.2 billion, a 9% increase from the same period last year, or 11% when adjusted for foreign exchange. The company's growth portfolio revenues reached $5.6 billion, marking an 18% increase. U.S. revenues rose 13% to $8.8 billion, while international revenues fell 1% to $3.4 billion.
GAAP EPS was $0.83, a 16% decrease, and Non-GAAP EPS was $2.07, an 18% increase. The company raised its 2024 non-GAAP guidance, forecasting higher revenue and diluted EPS ranges.
Significant regulatory milestones include U.S. approvals for Breyanzi in follicular and mantle cell lymphoma and several ongoing regulatory reviews for subcutaneous nivolumab in the U.S. and EU.
R&D expenses surged by 28% to $2.9 billion due to an IPRD impairment charge, while gross margin on a non-GAAP basis improved slightly to 75.6%.
Bristol Myers Squibb (BMY) has announced that 100% of its marketed products are now supported by access plans, as part of its 10-year ASPIRE strategy to promote health equity and increase access to medicines in low- and middle-income countries (LMICs). The company aims to reach over 208,000 patients in LMICs by 2033. BMS is collaborating with the Access to Oncology Medicines (ATOM) Coalition to make Opdivo (nivolumab) available in select countries including Pakistan, Rwanda, and Zambia. This initiative is part of BMS's broader commitment to health equity and its Environmental, Social and Governance (ESG) strategy, focusing on reducing quality-of-care gaps and strengthening health systems globally.
Bristol Myers Squibb (BMY) has released its 2023 ESG Report, highlighting the company's commitment to environmental, social, and governance initiatives. The report emphasizes BMS's understanding that its future is interconnected with its employees, communities, and the planet. The company's ESG strategy aims to leverage its capabilities and resources to positively impact communities globally.
BMS's approach focuses on topics essential to its mission with opportunities for differentiation. The report showcases the company's progress and aspirational goals in areas beyond its core business of developing innovative medicines. This strategic focus demonstrates BMS's dedication to sustainable and responsible business practices, aligning with growing investor interest in ESG performance.
Bristol Myers Squibb (NYSE: BMY) announced that the European Medicines Agency (EMA) validated its Type II variation application for Opdivo (nivolumab) plus Yervoy (ipilimumab) as a first-line treatment for unresectable or advanced hepatocellular carcinoma (HCC). This validation initiates the EMA's review process.
The application is based on Phase 3 CheckMate -9DW trial results, which showed improved overall survival with Opdivo plus Yervoy compared to lenvatinib or sorafenib. No new safety signals were identified, and the safety profile was consistent with previous data. Results were presented at the 2024 ASCO Annual Meeting.
HCC is the most common type of primary liver cancer, representing 75%-85% of cases. Despite current treatments, advanced-stage HCC has poor prognosis, necessitating better therapeutic options.
Opdivo and Yervoy are approved across multiple regions and cancer types. They work by enhancing the body’s immune response to cancer, and have shown significant clinical benefits in various trials.
Bristol Myers Squibb (NYSE:BMY) has achieved a significant milestone in its environmental sustainability efforts. The Science Based Targets initiative (SBTi) has validated BMS' near-term and net-zero science-based targets, reinforcing the company's commitment to reducing greenhouse gas (GHG) emissions. BMS aims to reach net-zero GHG emissions across its value chain by 2050 from a 2022 baseline.
Key commitments include:
- Reducing Scope 1 and 2 GHG emissions and Scope 3 GHG emissions by 54.6% by 2033
- Engaging 75% of suppliers, by emissions, in developing science-based targets by 2028
- Sourcing 100% purchased electricity from renewable sources by 2030
BMS has made progress through energy reduction projects, renewable energy agreements, and supplier engagement. The company has expanded its Scope 3 emissions tracking to 10 categories and received recognition for its energy management efforts.
Bristol Myers Squibb (NYSE: BMY) has announced its participation in the UBS Virtual Targeted Protein Degradation Day. The event will feature Robert Plenge, M.D., Ph.D., who is the Executive Vice President, Chief Research Officer, and Head of Research at BMY. Dr. Plenge will be part of a fireside chat on Monday, July 15, 2024, beginning at 11:00 a.m. ET, where he will discuss the company's initiatives and answer questions. Investors and the public can listen to the live webcast via the BMS investor website, with an archived version available after the event.
Bristol Myers Squibb (NYSE:BMY) has been named to the 2023 Dow Jones Sustainability Index (DJSI) North America. This recognition highlights the company's commitment to environmental, social, and governance (ESG) efforts. BMS has achieved significant progress in increasing workforce diversity, reducing its environmental footprint, and strengthening data privacy and cybersecurity measures. Additionally, BMS has incorporated ESG metrics into executive compensation to reinforce corporate governance. The DJSI North America includes the top 20% of the largest 600 North American companies in the S&P Global Broad Market Index, known for their outstanding economic, environmental, and social performance. Korab Zuka, BMS' vice president of Purpose and ESG, emphasized the company's dedication to improving sustainability practices and impacting global health positively. More details on BMS' ESG strategy can be found in their 2023 ESG Report.
Bristol Myers Squibb (NYSE: BMY) announced the U.S. FDA's accelerated approval of KRAZATI® (adagrasib) in combination with cetuximab for adult patients with previously treated KRAS G12C-mutated locally advanced or metastatic colorectal cancer (CRC).
The approval is based on positive results from the Phase 1/2 KRYSTAL-1 study, which showed an objective response rate (ORR) of 34% in patients with heavily pretreated CRC. The median duration of response (DOR) was 5.8 months. This combination therapy provides a new treatment option for CRC patients who have not responded well to prior therapies.
KRAZATI is the first KRAS G12C inhibitor approved beyond non-small cell lung cancer, marking a significant milestone for BMS and reinforcing the potential of KRAZATI across various tumor types.
However, it comes with warnings and precautions including gastrointestinal adverse reactions, QTc interval prolongation, hepatotoxicity, and interstitial lung disease. The most common adverse reactions include rash, nausea, diarrhea, fatigue, and musculoskeletal pain.
