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NEW YORK - Pfizer Inc. (NYSE: NYSE:PFE), a pharmaceutical giant with a market capitalization of $150 billion and annual revenue exceeding $59 billion, announced today that its Phase 3 BREAKWATER study of BRAFTOVI (encorafenib) in combination with cetuximab and mFOLFOX6 has yielded positive results for patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation. According to InvestingPro, Pfizer maintains a "GOOD" financial health score, positioning it well to advance its drug development initiatives. The study showed a significant improvement in progression-free survival (PFS) and overall survival (OS), which are primary and secondary endpoints, respectively.
The BRAFTOVI combination regimen had previously received accelerated approval from the U.S. Food and Drug Administration (FDA) in December 2024 for treatment-naïve patients based on its improvement in the objective response rate (ORR). The latest findings from the BREAKWATER study are expected to be discussed with the FDA as Pfizer seeks to convert this to full approval. With a substantial dividend yield of 6.49% and a 14-year track record of consecutive dividend increases, Pfizer continues to reward shareholders while investing in breakthrough treatments. Discover more dividend insights and financial metrics with InvestingPro’s comprehensive analysis tools. The results will also be shared with other global health authorities to support potential additional license applications.
The BREAKWATER trial, a randomized, active-controlled, open-label, multicenter study, compared the efficacy of BRAFTOVI with cetuximab and mFOLFOX6 against standard chemotherapy with or without bevacizumab. The safety profile of the BRAFTOVI combination was consistent with the known safety profiles of the individual components, with no new safety signals identified.
Colorectal cancer is the third most common cancer worldwide, with over 1.8 million new cases in 2022. It is also the second leading cause of cancer-related deaths. BRAF mutations, which occur in 8-12% of mCRC patients, are associated with a poor prognosis, making the development of targeted therapies like BRAFTOVI crucial.
The BRAFTOVI combination regimen is part of Pfizer’s commitment to advancing cancer care through its extensive oncology portfolio and pipeline, which includes small molecules, antibody-drug conjugates (ADCs), and bispecific antibodies.
This news is based on a press release statement and the information has been presented without any promotional language or subjective assessment. The focus is on the potential impact of BRAFTOVI for patients with mCRC with a BRAF V600E mutation, reflecting Pfizer’s dedication to providing innovative cancer treatments. Based on InvestingPro’s Fair Value analysis, Pfizer currently appears undervalued, with analysts maintaining a moderate buy consensus and projecting net income growth for the coming year. For detailed valuation insights and exclusive financial analysis, explore InvestingPro’s comprehensive research report, available for over 1,400 US stocks including Pfizer.
In other recent news, Moderna Inc (BMV:MRNA)’s stock climbed following comments by RFK Jr, which appeared to boost investor confidence in the biotechnology company. Meanwhile, Pfizer Inc avoided a potential standoff with activist investor Starboard Value LP, as the latter refrained from nominating directors to Pfizer’s board. Pfizer also plans to sell a 7.7% stake in Haleon Plc, potentially raising $3.1 billion, according to Bloomberg.
In the biopharma sector, Bernstein analysts highlighted Eli Lilly and Company (NYSE:LLY) as their top pick. The analysts anticipate a more favorable mergers and acquisitions climate and lessened pricing concerns, despite persisting global pressures. They also see potential in Eli Lilly’s orforglipron treatment, adding to the company’s valuation and leadership status.
Vaccine manufacturers Moderna (NASDAQ:MRNA) and Novavax (NASDAQ:NVAX) have seen advances in trading due to an increase in seasonal flu cases. Pfizer has been granted FDA approval for BRAFTOVI® in combination with cetuximab and mFOLFOX6 for the treatment of metastatic colorectal cancer with a BRAF V600E mutation. These are among the recent developments that investors should note.
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