Bristol-Myers Squibb Co. - BMY STOCK NEWS

Bristol Myers Squibb (NYSE: BMY) will present research on its cardiovascular portfolio at the European Society of Cardiology (ESC) Congress 2024 in London. Key presentations include:

1. Long-term efficacy and safety data on CAMZYOS® (mavacamten) for obstructive hypertrophic cardiomyopathy (oHCM) up to 3.5 years

2. Pharmacodynamic biomarker analysis for milvexian from the AXIOMATIC-TKR study

3. Gender and racial differences in outcomes for Medicare beneficiaries with non-valvular atrial fibrillation treated with oral anticoagulants, including ELIQUIS® (apixaban)

The presentations demonstrate BMY's commitment to advancing cardiovascular treatments. The company will showcase developments in anticoagulation, thrombosis management, and oHCM treatment.

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.