PRINCETON, N.J. - Bristol Myers Squibb (NYSE: NYSE:BMY) has announced the European Medicines Agency's (EMA) validation of its application for Opdivo® (nivolumab) in combination with Yervoy® (ipilimumab) as a first-line treatment for adults with unresectable or advanced hepatocellular carcinoma (HCC). This validation marks the commencement of the EMA's centralized review process.
The application is supported by data from the Phase 3 CheckMate -9DW trial, which showed a statistically significant and clinically meaningful improvement in overall survival for patients treated with the Opdivo plus Yervoy combination compared to those given the choice of lenvatinib or sorafenib. The safety profile was consistent with previous findings, with no new safety signals identified.
Liver cancer, particularly HCC, is a leading cause of cancer death globally, and the prognosis for patients with advanced disease remains poor. The need for therapies that can deliver better clinical outcomes is critical, as highlighted by Dana Walker, M.D., M.S.C.E., vice president at Bristol Myers Squibb.
The CheckMate -9DW trial involved approximately 668 patients randomized to receive either the Opdivo plus Yervoy combination or the current standard of care. The primary endpoint was overall survival, with secondary endpoints including objective response rate and time to symptom deterioration.
Opdivo, a PD-1 immune checkpoint inhibitor, and Yervoy, which targets CTLA-4, are part of Bristol Myers Squibb's Immuno-Oncology portfolio, which is underpinned by a broad range of clinical trials across various tumor types. The company's commitment to cancer research aims to deliver medicines that can offer improved, healthier lives to patients and potentially cure.
The validation of the application by the EMA does not guarantee approval but confirms the completeness of the submission for review. Bristol Myers Squibb expressed gratitude to the patients and investigators involved in the CheckMate -9DW clinical trial.
This news is based on a press release statement.
In other recent news, Bristol Myers Squibb has seen several significant developments. The U.S. Food and Drug Administration (FDA) has approved the company's combination therapy, including the oral drug Krazati, for treating colorectal cancer in patients with a specific genetic mutation. The FDA also gave accelerated approval for Augtyro as a treatment for certain patients with solid tumors.
Furthermore, the company announced the appointment of Michael R. McMullen to its Board of Directors.
However, Bristol Myers Squibb, along with Sanofi (EPA:SASY) (NASDAQ:SNY), has been ordered to pay over $916 million to the state of Hawaii due to allegations of failure to adequately warn non-white patients about potential health risks associated with the blood thinner Plavix. Both companies plan to appeal the decision.
Despite this, Citi maintained its Buy rating on Bristol Myers Squibb stocks, citing the company's financial health and the potential of its pipeline. These are among the recent developments in the company's journey.
InvestingPro Insights
As Bristol Myers Squibb (NYSE: BMY) awaits the European Medicines Agency's review of Opdivo® and Yervoy® for hepatocellular carcinoma, the company's financial health and market performance offer insights into its operational stability during this pivotal period. According to InvestingPro data, Bristol Myers Squibb has a market capitalization of 85.93 billion USD, a testament to its significant presence in the pharmaceutical industry. The company's revenue in the last twelve months as of Q1 2024 stands at 45.53 billion USD, with a robust gross profit margin of 76.03%, indicating efficient management and strong pricing power.
Investors might find comfort in the company's dividend yield, which is 5.66%, demonstrating a commitment to returning value to shareholders. Furthermore, the company's long-standing policy of dividend payments, which has been maintained for 54 consecutive years, is a reassuring sign of financial stability and shareholder loyalty. This dedication to dividends is particularly noteworthy in an industry where reinvestment is critical for sustained innovation and growth.
Two InvestingPro Tips highlight key aspects of Bristol Myers Squibb's strategic management: the aggressive share buyback program implemented by management, suggesting confidence in the company's intrinsic value, and the strong free cash flow yield, which implies that the company is generating ample cash to support its operations and strategic initiatives. These factors may be especially relevant as the company continues to invest in clinical trials and seeks to expand its Immuno-Oncology portfolio.
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