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PRINCETON, N.J. - The U.S. Food and Drug Administration (FDA) has accepted a supplemental biologics license application (sBLA) from Bristol Myers Squibb (NYSE:BMY), a prominent pharmaceutical company with $48.3 billion in annual revenue and an impressive 75% gross profit margin, for Opdivo® (nivolumab) in combination with Yervoy® (ipilimumab). According to InvestingPro data, BMY maintains a strong market position with over $113 billion in market capitalization. This dual immunotherapy treatment is intended for adult and pediatric patients (12 years and older) with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (mCRC). The FDA has granted the application Breakthrough Therapy Designation, Priority Review status, and set a target action date of June 23, 2025.
The application for this first-line treatment option is supported by results from the Phase 3 CheckMate -8HW clinical trial. The trial demonstrated superior progression-free survival for the Opdivo plus Yervoy combination compared to both Opdivo monotherapy and investigator’s choice of chemotherapy. Dana Walker, M.D., M.S.C.E., vice president, Opdivo global program lead at Bristol Myers Squibb, stated that this milestone brings the company closer to offering an effective treatment for this patient group.
The dual therapy has previously received FDA approval in July 2018 for certain patients with MSI-H or dMMR mCRC who have progressed following specific treatments. Moreover, in December 2024, the European Union and in October 2024, the China National Medical (TASE:BLWV) Products Administration (NMPA) approved the combination for similar indications. InvestingPro analysis shows BMY’s strong financial health with substantial free cash flow generation, supporting its ongoing research and development initiatives.
CheckMate -8HW is an ongoing study, continuing to assess secondary endpoints, including overall survival. The safety profile for the combination has been consistent with previous reports and manageable with established protocols, with no new safety signals identified.
Colorectal cancer is the third most commonly diagnosed cancer worldwide, and approximately 5-7% of metastatic CRC patients have dMMR or MSI-H tumors. These patients typically have a poor prognosis and are less likely to benefit from conventional chemotherapy. For investors, BMY offers a compelling 4.44% dividend yield and appears undervalued according to InvestingPro Fair Value metrics. Get access to the full BMY Pro Research Report and 8 additional ProTips to make informed investment decisions.
The FDA’s acceptance of this sBLA is based on a press release statement from Bristol Myers Squibb.
In other recent news, Bristol Myers Squibb reported its fourth-quarter 2024 earnings, surpassing analyst expectations with an earnings per share of $1.67 and revenue of $12.34 billion, both exceeding forecasts. The company also announced positive outcomes from its Phase 2 TRANSCEND FL trial, where Breyanzi met its primary endpoint in patients with marginal zone lymphoma. Meanwhile, Bristol Myers Squibb faced a setback with its Phase 3 RELATIVITY-098 trial for Opdualag in melanoma, as it did not meet its primary endpoint of recurrence-free survival. In another development, Bristol Myers Squibb disclosed promising results from the CheckMate -816 study, where Opdivo combined with chemotherapy showed a significant survival benefit for lung cancer patients. Additionally, Goldman Sachs raised its price target for Bristol Myers Squibb to $67, maintaining a Buy rating, highlighting the company’s strong fourth-quarter performance and potential growth drivers. The company also announced plans for further cost reductions, expecting $1 billion in savings by 2025 and an additional $1 billion by 2027. These recent developments reflect Bristol Myers Squibb’s strategic focus on innovation and cost management.
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