Wednesday, January 28, 2026
Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Cardiff Made Two Significant Announcements. New data from the Phase 2 CRDF-004 trial testing onvansertib as a first line treatment for metastatic colorectal cancer was announced as expected. Patients in the high-dose onvansertib group showed a large benefit in overall response rates (ORR) and progression free survival (PFS). Separately, the CEO and CFO have left the company. Board Member Dr. Mani Mohindru was named Interim CEO.
Phase 2 Trial Design. As discussed in our January 5 report, CDRF-004 is a Phase 2 dose-finding trial testing two doses of onvansertib in combination with two standard-of-care (SOC) regimens against the standard of care regimens alone. It enrolled 110 patients with RAS-mutated metastatic colorectal cancer, mCRC. Its primary endpoint is objective response rate (ORR). Secondary endpoints include progression-free survival (PFS), duration of response (DOR) and safety. These endpoints were selected to guide the design of Phase 3.
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