Diffusion Pharmaceuticals Inc (NASDAQ: DFFN) is seeing big gains early on in the market this morning, and for good reason. The company announced that it received FDA approval surrounding enrollment in a key clinical trial. Of course, the news excited investors who are sending the stock to the moon. Today, we’ll talk about:
- The regulatory update;
- what we’re seeing from DFFN stock as a result; and
- what we’ll be watching for ahead.
DFFN Announces Regulatory Update
As mentioned above, Diffusion Pharmaceuticals is headed for the top in the market this morning after the company announced a regulatory update. In a press release issued early today, the company said that it received FDA approval to enroll patients in an ambulance-based Phase 2 clinical trial. The trial is designed to test the company’s lead drug, trans sodium crocetinate (TSC), for the treatment of acute stroke.
In the release, DFFN said that the clinical trial, known as PHAST-TSC (Pre-Hospital Ambulance Stroke Trial-TSC), will include 23 hospitals across urban, suburban and rural areas in Los Angeles and Central Virginia. With the trial set to initiate enrollment, the company said that results could be available in just under two years. In a statement, John L. Gainer, PhD, CSO at DFFN and inventor of the TSC molecule, had the following to offer:
Dr. Saver and his team at UCLA have been pioneers in on-ambulance therapy, and, along with Dr. Johnston and her team at the University of Virginia, we have the expertise necessary to test TSC’s effectiveness in patients suffering from acute stroke… While combining the talents of a pharmaceutical company with those of two of our country’s leading academic medical centers is, perhaps, a paradigm shift for creating new clinical trials, it is one which will hopefully produce substantial benefits for stroke victims and their families.
The above statement was followed up by David Kalergis, Chairman and CEO at DFFN. Here’s what he had to offer:
TSC was originally designed for the US military to help treat life-threatening injuries on the battlefield – a place where every minute can be the difference between life and death. This FDA approval to begin patient enrollment in PHAST-TSC gives us the opportunity to show that treatment with TSC could make an impact on a different battlefield, one where stroke patients are also in a race against the clock… As we return to our company’s roots in emergency medicine and work to identify possible strategic partnerships, we will also continue applying TSC to other areas of medicine, including GBM brain cancer in our ongoing Phase 3 trial.
What We’re Seeing From The Stock
One of the first lessons that we learn when we start to dig into the market is that the news leads to moves. In the case of Diffusion Pharmaceuticals, the news proved to be overwhelmingly positive. Under 2 years from enrollment to published results is a very fast timeframe and the news brings the company one step closer to commercialization. So, it comes as no surprise that excited investors are sending the stock screaming for the top. Of course, our partners at Trade Ideas were the first to alert us to the gains. At the moment (10:11), DFFN is trading at $0.62 per share after a gain of $0.14 per share or 30.31% thus far today.
Stop wasting your time! Start finding winning trades in minutes with Trade Ideas!
What We’ll Be Watching For Ahead
Moving forward, the CNA Finance team will continue to keep a close eye on DFFN. In particular, we’re interested in following the story surrounding the company’s continued work to bring the TSC molecule to market. Nonetheless, we’ll keep a close eye on the news and bring it to you as it breaks!
Never Miss The News Again
Do you want real-time, actionable news delivered to your inbox? Join the CNA Finance mailing list below!