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Cardiff (CRDF) Stock Rallies 194% in a Month: Here's Why
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Cardiff Oncology, Inc. (CRDF - Free Report) is developing novel therapeutic candidates to treat various types of cancer, with an initial focus on RAS-mutated metastatic colorectal cancer (mCRC) and metastatic pancreatic ductal adenocarcinoma (mPDAC) indications.
Cardiff’s pipeline only comprises its lead investigational candidate, onvansertib, which is currently being evaluated in combination with standard-of-care (SOC) therapeutics in separate early to mid-stage studies to treat mCRC and mPDAC.
Onvansertib is an oral and small-molecule drug candidate that is highly specific for PLK1 inhibition.
In the past month, shares of CRDF have skyrocketed 193.5% against the industry’s 1.7% decline. The massive surge in the stock price has been fueled by an encouraging update from the company’s developmental program for onvansertib in the mCRC indication.
Image Source: Zacks Investment Research
Last month, Cardiff announced that the first patient was dosed in its phase II CRDF-004 study of onvansertib in patients with first-line RAS-mutated mCRC. The mid-stage study is being conducted by Pfizer’s (PFE - Free Report) new end-to-end service for biotech companies, Pfizer Ignite.
The arrangement allows Cardiff to leverage Pfizer Ignite’s execution capabilities to advance the development of onvansertib.
The CRDF-004 study is evaluating the safety and efficacy of 20mg and 30mg doses of onvansertib in combination with SOC (Folfiri and bevacizumab or Folfox and bevacizumab) compared with SOC alone to treat the first-line RAS-mutated mCRC patient population. The mid-stage study is designed to confirm the dose strength of onvansertib for a subsequent registrational study.
The primary endpoint of the CRDF-004 study is objective response rate (ORR), while secondary endpoints include progression-free survival (PFS), duration of response and safety. Top-line data readout from the mid-stage study is expected in mid-2024.
Subject to positive results from the phase II CRDF-004 study, Cardiff plans to initiate a phase III CRDF-005 registrational study for the onvansertib/SOC combo to treat patients with first-line RAS-mutated mCRC.
Furthermore, the FDA has also agreed with the company that an interim analysis of ORR in the planned registrational study can provide the basis for an application seeking approval for the onvansertib/SOC combo under an accelerated pathway. Under such circumstances, PFS and overall survival data will be designated as endpoints for full approval.
We note that last year, Cardiff discontinued its phase II ONSEMBLE study evaluating onvansertib in combination with SOC therapy to treat patients with second-line RAS-mutated mCRC. The strategic decision was taken to focus the company's resources on its phase II CRDF-004 study in the first-line setting, where there is a higher unmet need.
Besides the mCRC indication, CRDF is also currently evaluating the safety and preliminary efficacy of onvansertib in combination with Onyvide (nanoliposomal irinotecan), fluorouracil and leucovorin in a phase II CRDF-001 study to treat second-line patients with mPDAC.
In the past 30 days, the Zacks Consensus Estimate for ADMA Biologics’ 2024 earnings per share (EPS) has increased from 22 cents to 30 cents. During the same period, the estimate for ADMA’s 2025 EPS has increased from 32 cents to 50 cents. In the past month, shares of ADMA have jumped 20.2%.
ADMA beat estimates in three of the trailing four quarters and matched in one, delivering an average earnings surprise of 85%.
In the past 30 days, the Zacks Consensus Estimate for FibroGen’s 2024 loss per share has narrowed from $1.14 to $1.09. During the same period, the estimate for FibroGen’s 2025 loss per share is pegged at 6 cents. In the past month, shares of FGEN have plunged 24.9%.
FGEN beat estimates in two of the trailing four quarters, missing the mark on the other two occasions, delivering an average negative surprise of 2.26%.
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Cardiff (CRDF) Stock Rallies 194% in a Month: Here's Why
Cardiff Oncology, Inc. (CRDF - Free Report) is developing novel therapeutic candidates to treat various types of cancer, with an initial focus on RAS-mutated metastatic colorectal cancer (mCRC) and metastatic pancreatic ductal adenocarcinoma (mPDAC) indications.
Cardiff’s pipeline only comprises its lead investigational candidate, onvansertib, which is currently being evaluated in combination with standard-of-care (SOC) therapeutics in separate early to mid-stage studies to treat mCRC and mPDAC.
Onvansertib is an oral and small-molecule drug candidate that is highly specific for PLK1 inhibition.
In the past month, shares of CRDF have skyrocketed 193.5% against the industry’s 1.7% decline. The massive surge in the stock price has been fueled by an encouraging update from the company’s developmental program for onvansertib in the mCRC indication.
Image Source: Zacks Investment Research
Last month, Cardiff announced that the first patient was dosed in its phase II CRDF-004 study of onvansertib in patients with first-line RAS-mutated mCRC. The mid-stage study is being conducted by Pfizer’s (PFE - Free Report) new end-to-end service for biotech companies, Pfizer Ignite.
The arrangement allows Cardiff to leverage Pfizer Ignite’s execution capabilities to advance the development of onvansertib.
The CRDF-004 study is evaluating the safety and efficacy of 20mg and 30mg doses of onvansertib in combination with SOC (Folfiri and bevacizumab or Folfox and bevacizumab) compared with SOC alone to treat the first-line RAS-mutated mCRC patient population. The mid-stage study is designed to confirm the dose strength of onvansertib for a subsequent registrational study.
The primary endpoint of the CRDF-004 study is objective response rate (ORR), while secondary endpoints include progression-free survival (PFS), duration of response and safety. Top-line data readout from the mid-stage study is expected in mid-2024.
Subject to positive results from the phase II CRDF-004 study, Cardiff plans to initiate a phase III CRDF-005 registrational study for the onvansertib/SOC combo to treat patients with first-line RAS-mutated mCRC.
Furthermore, the FDA has also agreed with the company that an interim analysis of ORR in the planned registrational study can provide the basis for an application seeking approval for the onvansertib/SOC combo under an accelerated pathway. Under such circumstances, PFS and overall survival data will be designated as endpoints for full approval.
We note that last year, Cardiff discontinued its phase II ONSEMBLE study evaluating onvansertib in combination with SOC therapy to treat patients with second-line RAS-mutated mCRC. The strategic decision was taken to focus the company's resources on its phase II CRDF-004 study in the first-line setting, where there is a higher unmet need.
Besides the mCRC indication, CRDF is also currently evaluating the safety and preliminary efficacy of onvansertib in combination with Onyvide (nanoliposomal irinotecan), fluorouracil and leucovorin in a phase II CRDF-001 study to treat second-line patients with mPDAC.
Cardiff Oncology, Inc. Price and Consensus
Cardiff Oncology, Inc. price-consensus-chart | Cardiff Oncology, Inc. Quote
Zacks Rank and Other Stocks to Consider
Cardiff currently carries a Zacks Rank #2 (Buy).
Some other top-ranked stocks from the drug/biotech industry worth mentioning are ADMA Biologics (ADMA - Free Report) and FibroGen (FGEN - Free Report) . While ADMA sports a Zacks Rank #1 (Strong Buy), FGEN carries a Zacks Rank #2 at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 30 days, the Zacks Consensus Estimate for ADMA Biologics’ 2024 earnings per share (EPS) has increased from 22 cents to 30 cents. During the same period, the estimate for ADMA’s 2025 EPS has increased from 32 cents to 50 cents. In the past month, shares of ADMA have jumped 20.2%.
ADMA beat estimates in three of the trailing four quarters and matched in one, delivering an average earnings surprise of 85%.
In the past 30 days, the Zacks Consensus Estimate for FibroGen’s 2024 loss per share has narrowed from $1.14 to $1.09. During the same period, the estimate for FibroGen’s 2025 loss per share is pegged at 6 cents. In the past month, shares of FGEN have plunged 24.9%.
FGEN beat estimates in two of the trailing four quarters, missing the mark on the other two occasions, delivering an average negative surprise of 2.26%.