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SAN DIEGO - Cardiff Oncology, Inc. (NASDAQ:CRDF), a clinical-stage biotech company with a market capitalization of $220 million, announced positive data from its ongoing Phase 2 clinical trial evaluating onvansertib in combination with standard-of-care (SoC) for patients with first-line RAS-mutated metastatic colorectal cancer. The company’s stock has shown impressive momentum, delivering a 62% return over the past year, according to InvestingPro data.
The trial demonstrated a 49% confirmed objective response rate (ORR) in the 30mg onvansertib dose arm versus 30% in the control arm in the intent-to-treat population of 110 patients, according to a company press release. Early progression-free survival data showed a trend favoring the 30mg onvansertib dose arm compared to the control arm. While the clinical results are promising, InvestingPro analysis shows the company maintains a strong financial position with more cash than debt on its balance sheet, though it’s currently burning through cash rapidly.
The CRDF-004 trial enrolled patients with metastatic colorectal cancer who have documented KRAS or NRAS mutations. Patients were randomized to receive either 20mg of onvansertib plus SoC, 30mg of onvansertib plus SoC, or SoC alone.
Data showed that confirmed ORR at six months was 46% in the 30mg arm compared to 22% in the control arm. Spider plots demonstrated deeper responses in patients receiving the 30mg dose compared to both the control arm and 20mg dose arm.
The safety analysis, conducted on 104 patients, indicated that onvansertib in combination with chemotherapy and bevacizumab was well-tolerated with no major or unexpected toxicities observed. Neutropenia was reported as the most common treatment-emergent adverse event associated with onvansertib.
"We are highly encouraged by the 19% improvement in confirmed ORR as well as the shorter time to response and deeper tumor regression observed in our trial with onvansertib combined with SoC compared to SoC alone," said Roger Sidhu, Chief Medical Officer of Cardiff Oncology, in the press release.
The company expects to provide an update on its first-line metastatic colorectal cancer program by the first quarter of 2026. With analysts maintaining a Strong Buy consensus and setting price targets significantly above current levels, investors seeking deeper insights can access comprehensive analysis through InvestingPro, which offers exclusive financial health scores and 12 additional ProTips for Cardiff Oncology.
In other recent news, Cardiff Oncology has reported positive results from a Phase 1b clinical trial for their drug onvansertib, in combination with paclitaxel, targeting metastatic triple-negative breast cancer. This trial aimed to determine the safety and optimal dosing of the drug combination. H.C. Wainwright has also increased its price target for Cardiff Oncology to $18, maintaining a Buy rating. The firm expects updated results from the CRDF-004 trial, which is focused on onvansertib as a treatment for RAS-mutated colorectal cancer. Ladenburg Thalmann initiated coverage on Cardiff Oncology with a Buy rating and a $19 price target, citing the potential of onvansertib in treating colorectal cancer with KRAS and NRAS mutations. In leadership changes, Cardiff Oncology appointed Roger Sidhu as the new Chief Medical Officer, bringing over 20 years of oncology experience. Dr. Sidhu replaces Dr. Fairooz Kabbinavar, who will continue with the company in an advisory capacity. These developments reflect Cardiff Oncology’s ongoing efforts in advancing cancer treatment options.
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