PRINCETON, N.J. - Bristol Myers Squibb (NYSE: NYSE:BMY) has announced the U.S. Food and Drug Administration's (FDA) acceptance of a supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) in combination with Yervoy (ipilimumab). This potential treatment is for adults with unresectable hepatocellular carcinoma (HCC), the most prevalent form of liver cancer. The FDA's target action date for a decision is April 21, 2025.
The application is supported by data from the Phase 3 CheckMate -9DW trial, which demonstrated a statistically significant and clinically meaningful improvement in overall survival for patients treated with the Opdivo plus Yervoy combination compared to those receiving lenvatinib or sorafenib, the current standard treatments. The safety profile of the combination therapy was consistent with past findings and considered manageable.
HCC is often diagnosed at an advanced stage when surgical options are no longer viable, highlighting the need for new first-line systemic therapies. The current standard treatments can have limited effectiveness, and a high recurrence rate within five years post-treatment is common. Given the increasing HCC incidence in the U.S., the potential approval of this combination therapy could provide a new option for patients who have not undergone systemic therapy.
Bristol Myers Squibb expressed gratitude to the patients and investigators participating in the CheckMate -9DW trial, emphasizing the importance of their contribution to advancing HCC treatment.
The CheckMate -9DW trial, which included 668 patients, evaluated the efficacy of the Opdivo plus Yervoy combination against the investigator's choice of lenvatinib or sorafenib. The primary endpoint of the study was overall survival, with secondary endpoints including objective response rate and time to symptom deterioration.
Opdivo, a PD-1 immune checkpoint inhibitor, and Yervoy, a CTLA-4 inhibitor, are part of Bristol Myers Squibb's immuno-oncology portfolio, which includes a range of clinical trials across various cancer types. The combination has been previously approved as a second-line treatment for advanced HCC and has been used in more than 35,000 patients within clinical development programs.
This news is based on a press release statement from Bristol Myers Squibb.
In other recent news, Bristol Myers Squibb seeks approval from the European Medicines Agency (EMA) to extend the use of Breyanzi for certain follicular lymphoma patients, following promising results from the Phase 2 TRANSCEND FL study. Concurrently, Japan's Ministry of Health, Labour and Welfare has approved Breyanzi for high-risk follicular lymphoma patients, marking its third approval in Japan.
Bristol Myers Squibb's blood thinner Eliquis has been selected by the Biden administration for price negotiations with the Medicare health program. This is part of the Inflation Reduction Act's efforts to control drug prices.
TD Cowen has revised its price target for Bristol Myers Squibb to $53.00 from the previous $45.00, maintaining a Hold rating. This comes after a review of the company's financial model and an upward revision of estimates through 2030.
Executives from Bristol Myers Squibb have indicated that the first round of U.S. Medicare price negotiations is unlikely to substantially affect their business. This is in line with comments from Johnson & Johnson, AbbVie (NYSE:ABBV), and AstraZeneca (NASDAQ:AZN), which manufacture five of the ten drugs selected for initial price discussions.
Goldman Sachs (NYSE:GS) has adjusted its stance on Bristol Myers Squibb, raising the price target from $55.00 to $57.00 and reaffirming a Buy rating. The adjustment follows Bristol Myers' significant market performance and a review of its recent achievements and future outlook.
InvestingPro Insights
Bristol Myers Squibb (NYSE: BMY) has recently made headlines with its FDA application for a new liver cancer treatment. As investors evaluate the potential impact of this development on the company's financials, several metrics from InvestingPro offer a glimpse into Bristol Myers Squibb's current performance.
InvestingPro Data shows that Bristol Myers Squibb holds a market capitalization of $99.3 billion, reflecting its significant presence in the pharmaceutical industry. The company's P/E ratio stands at -15.21, but when adjusted for the last twelve months as of Q2 2024, it improves to 13.95. This adjustment indicates a more favorable earnings outlook than the unadjusted figure might suggest. Additionally, the company has experienced revenue growth of 2.93% over the last twelve months as of Q2 2024, signaling a steady upward trajectory in its financial performance.
An InvestingPro Tip points out that Bristol Myers Squibb has maintained dividend payments for 54 consecutive years, showcasing its commitment to returning value to shareholders. This is particularly noteworthy for investors looking for stable income streams. Another tip reveals that despite 14 analysts revising their earnings downwards for the upcoming period, the company's valuation implies a strong free cash flow yield, suggesting that the stock could be undervalued relative to its cash-generating ability.
For investors seeking further insights, there are additional InvestingPro Tips available, including information on share buybacks, industry positioning, and profitability forecasts. These tips can be found at https://www.investing.com/pro/BMY, offering a more comprehensive analysis to help inform investment decisions.
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