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THOUSAND OAKS - Amgen (NASDAQ:AMGN), a prominent biotechnology company with a market capitalization of $149 billion and strong financial health according to InvestingPro analysis, announced Monday that its Phase 3 FORTITUDE-101 clinical trial evaluating bemarituzumab plus chemotherapy met its primary endpoint of overall survival in patients with gastric or gastroesophageal junction cancer.
The trial demonstrated a statistically significant and clinically meaningful improvement in overall survival compared to placebo plus chemotherapy in patients with FGFR2b overexpression who are non-HER2 positive, according to a company press release. This development comes as Amgen maintains a robust gross profit margin of 69% and has achieved 15.6% revenue growth over the past year.
The study involved 547 patients across 300 sites in 37 countries. FGFR2b overexpression was defined as 2+/3+ staining in at least 10% of tumor cells by centrally performed immunohistochemistry testing.
"Most patients with gastric cancer are diagnosed at an advanced stage, with poor prognosis, low survival rates and limited therapeutic options," said Jay Bradner, executive vice president of Research and Development at Amgen.
Gastric cancer represents a significant global health burden as the fifth leading cause of cancer-related death worldwide, with nearly one million new cases and over 650,000 deaths annually.
The most common treatment-emergent adverse events in patients receiving bemarituzumab plus chemotherapy included reduced visual acuity, punctate keratitis, anemia, neutropenia, nausea, corneal epithelium defect and dry eye. Ocular events occurred with greater frequency and severity in the bemarituzumab arm compared to the placebo arm.
FORTITUDE-101 was conducted with support from Zai Lab, which holds co-development and commercialization rights for bemarituzumab in mainland China, Hong Kong, Macau, and Taiwan.
A separate Phase 3 study of bemarituzumab plus chemotherapy and nivolumab is ongoing in first-line gastric cancer patients, with results expected in the second half of 2025.
Detailed results from the FORTITUDE-101 trial will be presented at a future medical meeting. According to InvestingPro analysis, Amgen appears undervalued at current levels, with analysts projecting continued net income growth. For deeper insights into Amgen’s financial health and growth prospects, investors can access the comprehensive Pro Research Report, available exclusively to InvestingPro subscribers, along with 10+ additional ProTips and extensive financial metrics.
In other recent news, Amgen Inc. announced significant results from its Phase 2 study of the obesity treatment candidate, MariTide. The drug demonstrated up to 20% average weight loss in individuals with obesity without Type 2 diabetes and 17% in those with both conditions. Despite these promising results, investor reactions were mixed, potentially due to competitive pressures in the obesity drug market. The company has already started its Phase 3 MARITIME program to further evaluate MariTide’s efficacy and safety. In related developments, Piper Sandler adjusted its price target for Amgen to $328, maintaining an Overweight rating, citing increased R&D spending projections. The firm’s analyst highlighted the strong volume growth of Amgen’s products, such as Repatha and Tezspire, as a positive indicator for the company’s future. Additionally, Amgen shareholders recently approved executive compensation and ratified Ernst & Young LLP as independent accountants for the fiscal year. This shareholder meeting also saw the election of all 12 director nominees to one-year terms.
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