Cardiff Unveils Phase 1 Results of Onvensertib for Chronic Myelomonocytic Leukemia at ASH 2025
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 09 2025
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Source: NASDAQ.COM
Clinical Trial Results: Cardiff Oncology presented new data from a Phase 1 trial of onvansertib, a PLK1 inhibitor, for treating relapsed/refractory chronic myelomonocytic leukemia (CMML) at the ASH Annual Meeting, showing preliminary efficacy in about 40% of patients.
Drug Tolerability: Onvansertib was well-tolerated as a monotherapy, with manageable treatment-emergent adverse events reported among the nine enrolled patients.
Future Development Plans: Although Cardiff Oncology does not plan to further develop onvansertib for CMML, the results support its potential in treating various hematologic and solid tumors.
Stock Performance: Following the announcement, Cardiff Oncology's stock rose by 10.90% to $2.34, with a slight increase in after-hours trading, reflecting positive investor sentiment.
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Analyst Views on CRDF
Wall Street analysts forecast CRDF stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for CRDF is 13.67 USD with a low forecast of 10.00 USD and a high forecast of 19.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
6 Analyst Rating
6 Buy
0 Hold
0 Sell
Strong Buy
Current: 1.615
Low
10.00
Averages
13.67
High
19.00
Current: 1.615
Low
10.00
Averages
13.67
High
19.00
About CRDF
Cardiff Oncology, Inc. is a clinical-stage biotechnology company. It is leveraging PLK1 inhibition, a well-validated oncology drug target, to develop novel therapies across a range of cancers with unmet medical need. It is focused on clinical programs in indications, such as RAS-mutated metastatic colorectal cancer (mCRC), and in investigator-initiated trials in metastatic pancreatic ductal adenocarcinoma (mPDAC), small cell lung cancer (SCLC), and triple negative breast cancer (TNBC). Its lead drug candidate, Onvansertib, is an oral, small-molecule drug candidate that is highly specific for PLK1 inhibition with a 24-hour half-life. It has other ongoing and planned clinical trials of onvansertib: one trial (CRDF-004) in first-line treatment in patients with RAS-mutated mCRC, and investigator-initiated trials in first-line mPDAC, relapsed SCLC and unresectable locally advanced or metastatic TNBC.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Cardiff Oncology Management Shakeup and Trial Update
- Management Changes: Cardiff Oncology announced the resignation of CEO Mark Erlander and CFO James Levine, with board member Mani Mohindru appointed as interim CEO, reflecting a focus on execution and clinical advancement that may impact investor confidence negatively.
- Clinical Trial Data Update: In the CRDF-004 Phase 2 trial for RAS-mutated metastatic colorectal cancer, the 30 mg dose group achieved a confirmed objective response rate of 72.2%, significantly higher than the 43.2% in the standard care group, indicating the potential efficacy of the new drug and possibly driving future registrational trials.
- Registrational Trial Plans: Based on clinical data, Cardiff Oncology plans to initiate a registrational trial later this year comparing onvansertib with standard care for 1L patients, which, if successful, could help expand market share.
- Analyst Perspective: William Blair lowered the probability of success from 50% to 45%, suggesting that the abrupt management changes and narrow focus on onvansertib may limit market opportunities, leading to a 31.9% drop in stock price to $2, close to the 52-week low.
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Cardiff Oncology Shares Plunge 35% Following CEO and CFO Resignations
- Executive Departures: Cardiff Oncology's CEO Mark Erlander and CFO James Levine resigned, causing shares to plummet approximately 35% to a new 52-week low, indicating market concerns over leadership instability.
- Interim Leadership: The board appointed veteran biotech executive Mani Mohindru as interim CEO to replace Erlander, ensuring operational continuity during the executive transition period.
- Financial Stability: Brigitte Lindsay was promoted to Chief Accounting Officer to maintain the finance department's functionality, reflecting the company's commitment to financial management amid leadership changes.
- Clinical Trial Update: Cardiff announced plans to further test a 30 mg dose of its lead drug onvansertib in combination with FOLFIRI/bevacizumab, with a registrational trial expected to begin later this year pending FDA design confirmation, aiming to provide new treatment options for RAS-mutated metastatic colorectal cancer.
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