NEW YORK - Pfizer Inc. (NYSE: NYSE:PFE), a pharmaceutical giant with a market capitalization of $149.5B and impressive gross profit margins of nearly 70%, announced today that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for BRAFTOVI® (encorafenib) in combination with cetuximab and mFOLFOX6 for the treatment of metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, detected by an FDA-approved test. According to InvestingPro analysis, Pfizer currently appears undervalued, making it an interesting prospect for value investors. This approval is contingent on the verification of clinical benefit in ongoing trials.
The approval is based on results from the Phase 3 BREAKWATER trial, which showed a 61% overall response rate for the BRAFTOVI combination regimen compared to 40% in the control arm. The median duration of response was also longer at 13.9 months versus 11.1 months. The BREAKWATER trial is unique as it is the only Phase 3 trial for a BRAF-targeted therapy regimen in first-line BRAF V600E-mutant mCRC.
Scott Kopetz, M.D., Ph.D., FACP, from The University of Texas MD Anderson Cancer Center and co-principal investigator of the trial, noted the significance of this regimen, highlighting the high response rates that are rapid and durable, providing hope for patients with this aggressive form of cancer.
This accelerated approval is part of the FDA's Project FrontRunner, aimed at expediting the development and approval of cancer drugs for advanced or metastatic disease. The safety profile of BRAFTOVI in combination with cetuximab and mFOLFOX6 was consistent with the known safety profiles of the individual agents, with no new safety signals identified.
Pfizer has been a pioneer in delivering targeted therapies for molecular-driven cancers, and this latest approval expands their portfolio of innovative medicines in BRAF tumors. The company is also exploring a next-generation brain-penetrant BRAF inhibitor.
The BREAKWATER data are under discussion with other regulatory authorities globally to support potential future license applications for the BRAFTOVI combination regimen. The approval follows a previous FDA approval for BRAFTOVI in combination with cetuximab for adults with mCRC with a BRAF V600E mutation after prior therapy. As a prominent player in the pharmaceuticals industry, Pfizer continues to demonstrate strong financial health, with InvestingPro data showing consistent dividend payments for 54 consecutive years and maintaining a significant 6.67% dividend yield. For detailed analysis and 8 additional ProTips about Pfizer's financial outlook, investors can access the comprehensive Pro Research Report available on InvestingPro.
The information in this article is based on a press release statement from Pfizer Inc.
In other recent news, Pfizer Inc. has adjusted its growth projections and financial outlook. Truist Securities reduced Pfizer's price target to $32.00, maintaining a Buy rating. This adjustment reflects Pfizer's projected revenue growth of up to 5% operationally and an anticipated increase in adjusted diluted earnings per share (EPS) growth ranging from 10 to 18% operationally. Goldman Sachs also reaffirmed its Buy rating for Pfizer, projecting revenues of $64.9 billion and earnings per share of $3.13 for 2025.
In addition, Pfizer has raised its quarterly cash dividend to $0.43 per share for the first quarter of 2025. The company's earnings for the year 2025 are projected to align with current Wall Street projections, with adjusted earnings targeted between $2.80 and $3 per share. Pfizer also anticipates its revenue for 2025 to be between $61 billion and $64 billion, which is close to the $63.26 billion predicted by analysts.
Guggenheim adjusted its financial outlook for Pfizer, reducing the price target to $33.00 but maintained a Buy rating, while Leerink Partners reduced its price target from $31.00 to $28.00, keeping a Market Perform rating. These are recent developments in the company.
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