Cardiff Oncology Inc (NASDAQ: CRDF) is making its way for the top in the market this morning, and for good reason. The company announced that it received a Study May Proceed letter from the United States Food and Drug Administration (FDA). Here’s what’s going on:
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- Cardiff Oncology Announces Study May Proceed Letter
- Management Commentary
- What Analysts Think About CRDF Stock
- Risks to Consider Before Buying CRDF Stock
- Final Thoughts
Cardiff Oncology Announces Study May Proceed Letter
As mentioned above, Cardiff Oncology is headed for the top in the market today after announcing that it received a Study May Proceed letter from the FDA. The letter surrounded the Phase 2 clinical trial of onvansertib in metastatic pancreatic ductal adenocarcinoma.
CRDF went on to explain that the Phase 2 trial is designed to assess the safety and preliminary efficacy of onvansertib in combination with nanoliposomal irinotecan, 5-FU and leucovorin as a second-line treatment in patients with metastatic PDAC who have failed first-line gemcitabine-based therapy.
CRDF went on to explain that the trial will enroll about 40 patients across six sites in the United States. Three of these sites will be Mayo Clinic Cancer Centers. The other three sites are Emory University, Kansas University Medical Center, and Inova Schar Cancer Institute.
In a statement, Dr. Daniel H. Ahn, Medical Oncologist at the Mayo Clinic Cancer Center in Arizona and principal investigator for the Phase 2 PDAC trial, had the following to offer.
We are excited about the potential of onvansertib in PDAC and originally proposed this trial to Cardiff Oncology because of the results we are seeing in patients treated in our ongoing Phase 1b/2 trial in KRAS-mutated mCRC, which is also evaluating onvansertib in combination with nanoliposomal irinotecan and 5-FU.
These data show promising response rates with impressive durability across several KRAS variants following treatment. We believe these clinical benefits can be extended to PDAC, as approximately 95% have a KRAS mutation and onvansertib inhibits the proliferation and survival of KRAS-mutated tumor cells. We are looking forward to starting this important trial and providing our PDAC patients with a new second-line therapy with the potential to change the course of this devastating cancer.
The above comment was followed up by Mark Erlander, Ph.D., CEO at CRDF. Here’s what he had to offer:
The FDA’s clearance of our Investigational New Drug application for a Phase 2 clinical study in patients with metastatic pancreatic cancer is an important milestone for onvansertib and represents a significant step forward in our development of a potential new treatment in an indication where current therapeutic options are limited and patient prognosis is poor.
By parlaying the known synergy between onvansertib and standard-of-care nanoliposomal irinotecan and 5-FU therapy, we believe we can offer a promising new treatment option that has the potential to improve patient outcomes.
What Analysts Think About CRDF Stock
Analysts absolutely love CRDF stock as far as TipRanks is concerned. According to the platform, there are currently three analysts weighing in on the stock, all of which have a Buy rating. That’s right, no Holds, no Sells.
Moreover, the price target on the stock is compelling. With a low of $27 per share, a high of $30 per share and a median of $28.50 per share, the price targets suggest that there’s an opportunity for gains in multiples.
Keep in mind, analysts often work for companies with a vested interest in the stocks they cover. So, it’s never a good idea to blindly follow them as their opinions may be skewed. However, it is a good idea to use their opinions as a source of validation for your own.
Risks to Consider Before Buying CRDF Stock
There’s no such thing as an investment without risk. I hate when I see experts saying things like, “the stock can only go up.” The fact of the matter is that the stock can go in either direction, and you should always take a moment to consider the risks. When it comes to CRDF stock, the most significant risks to consider include:
- Clinical & Regulatory Risks. Cardiff Oncology is a clinical-stage biotechnology company. That means that it is at the mercy of clinical trials and regulatory agency views. Should a trial fail, or a regulatory agency deem data to be insufficient for approval to commercialize, the stock could experience significant declines.
- Capital Risk. As a clinical-stage biotechnology company, CRDF doesn’t generate revenue from sales. As such, it must survive with the cash it has in the bank. If that’s not enough to push the company to commercialization, and a profit, it may look to raise funds by selling newly-issued shares on the open market. Should this be the case, dilution and declines will likely be the result.
- Speculation. Any investment in a clinical-stage biotechnology company is one fueled by speculation. The fact of the matter is that nobody knows how the clinical trials will, how regulatory authorities will perceive applications, or how consumers will adopt products. If all goes well, the company could see dramatic gains, even climbing to blue-chip levels. But if one of these pieces doesn’t fall into place, significant declines could be the result.
Sure, there are risks to consider, there always are in the world of investing. However, at the moment, Cardiff Oncology stock looks like a promising option. The company is moving forward with Phase 2 trials, and if all goes well, will be pushing into late-stage trials.
Moreover, the company is attacking an indication that could drive billions of dollars in annual revenue through the doors, and has published promising data from past clinical trials. So, yes, there are risks, but yes, there’s also a tremendous potential opportunity here.