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PRINCETON, N.J. - Bristol Myers Squibb (NYSE: BMY), a prominent pharmaceutical company with a market capitalization of nearly $120 billion and impressive gross profit margins of 76%, received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for the use of Opdivo (nivolumab) in combination with Yervoy (ipilimumab) as a first-line treatment for adult patients with unresectable or advanced hepatocellular carcinoma (HCC). According to InvestingPro analysis, BMY maintains a strong financial health score, positioning it well for continued market expansion. This recommendation is based on Phase 3 CheckMate -9DW trial results presented in June 2024, which demonstrated a statistically significant and clinically meaningful improvement in overall survival for patients treated with the combination therapy compared to those receiving lenvatinib or sorafenib.
The trial showed a median overall survival (OS) of 23.7 months for patients treated with Opdivo plus Yervoy, versus 20.6 months for those treated with the current standard of care. The safety profile of the combination therapy was consistent with previous findings and no new safety signals were identified. This development comes as BMY’s stock shows strong momentum, with a 27% price return over the past six months, trading near its 52-week high of $61.10. The CHMP’s opinion will now be reviewed by the European Commission (EC), which has the authority to approve medicines within the EU.
Hepatocellular carcinoma, the most common type of liver cancer, often presents at an advanced stage where prognosis with existing treatments is generally poor. Dana Walker, M.D., M.S.C.E., vice president at Bristol Myers Squibb, expressed optimism about the CHMP’s opinion, noting it as a significant step in providing patients with additional treatment options.
The U.S. FDA also accepted a supplemental Biologics License Application (sBLA) for this combination as a potential first-line treatment for adult patients with unresectable HCC in August 2024, with a decision expected by April 21, 2025. The combination received accelerated approval from the FDA in 2020 based on Phase 2 trial results and has since been a second-line treatment for advanced HCC.
The CheckMate -9DW trial compared Opdivo plus Yervoy to the investigator’s choice of lenvatinib or sorafenib monotherapy in patients who had not received prior systemic therapy. With approximately 668 patients randomized, the primary endpoint was overall survival, with key secondary endpoints including objective response rate and time to symptom deterioration.
This news is based on a press release statement from Bristol Myers Squibb. With annual revenue exceeding $47 billion, BMY continues to demonstrate its market leadership in pharmaceutical innovation. Investors seeking deeper insights into BMY’s financial health and growth prospects can access comprehensive analysis through InvestingPro, which offers exclusive access to detailed financial metrics and expert research reports covering over 1,400 US stocks.
In other recent news, Bristol Myers Squibb has been making significant strides. The company has successfully completed Phase 3 trials of its drug Sotyktu for treating active psoriatic arthritis, marking a significant advancement in rheumatic conditions. It has also obtained approval from the European Commission for the use of Opdivo and Yervoy as a first-line treatment for certain types of colorectal cancer.
Additionally, Bristol Myers Squibb has entered into a collaboration with ArsenalBio for the development and potential commercialization of the AB-4000 series. This partnership aims to enhance the treatment of solid tumors through advanced cell engineering. Truist Securities maintained a Buy rating for the company, predicting revenues of $47.4 billion for 2024, $45.7 billion for 2025, and $42.8 billion for 2026.
TD Cowen, however, raised concerns about the global pharmaceutical industry’s future due to the impact of U.S. tariffs and geopolitical tensions, but noted that large-cap pharmaceutical companies, including Bristol-Myers Squibb (NYSE:BMY), are well-positioned to mitigate these risks. Meanwhile, Piper Sandler released a report detailing their top biotechnology picks for 2025 within the Central Nervous System vertical. These are just a few of the recent developments surrounding Bristol Myers Squibb.
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