VistaGen Therapeutics Inc (NASDAQ: VTGN) is having an overwhelmingly strong trading session in the market today, and for good reason. The company announced that it has received Fast Track Designation from the FDA. Of course, the news excited investors, sending the stock screaming for the top. Today, we’ll talk about:
- The Fast Track Designation;
- what we’re seeing from VTGN as a result; and
- what we’ll be watching for with regard to the stock ahead.
VTGN Announces Fast Track Designation
As mentioned above, VistaGen is having an incredibly strong trading session in the market today after the comapny announced that it has received Fast Track Designation. In a press release issued early this morning, the company said that the FDA has granted Fast Track Designation for the development of AV-101. AV-101 is a non-opiod, non-sedating treatment that is being developed for neuropathic pain. The FDA’s Fast Track designation is designed to facilitate the development, and potentially expedite the review, of drugs to treat serious or life-threatening conditions and fill an unmet medical need.
The Fast Track Designation is great news for VTGN and its investors. After all, with the designation comes increased support from the FDA in the development of AV-101 and a shorter road to regulatory approval.
In a statement, Shawn Singh, CEO at VTGN, had the following to offer:
Every day in the U.S., more than 115 people die from overdosing on opioids. We have evaluated AV-101 in multiple models of serious CNS conditions, including those that cause patients to suffer from neuropathic pain, for which current treatment options are inadequate. After considering peer-reviewed data published last year in The Journal of Pain, together with published safety data from our Phase 1 program, we believe AV-101 has the potential to address the high unmet need for a new non-opioid, non-sedating treatment for neuropathic pain… This important designation is especially timely given the FDA’s forceful commitment to address our nation’s opioid epidemic. The FDA’s Fast Track designation for development of AV-101 for neuropathic pain, together with the previously granted Fast Track designation for major depressive disorder, will allow our team to work closely with the FDA to bring AV-101 to patients affected by two of our country’s most debilitating and widespread healthcare concerns as soon as possible.
What We’re Seeing From The Stock
As investors, one of the first lessons that we learn is that the news moves the market. In the case of VistaGen, the news proved to be overwhelmingly positive. With the Fast Track Designation, the comapny’s time and financial investment required to bring AV-101 to market if all goes well has been reduced substantially. So, it comes as no surprise that excited investors are pushing the stock through the roof in the market today. As is normally the case, our partners at Trade Ideas were the first to alert us to the gains. At the moment (12:21), VTGN is trading at $2.17 per share after a gain of $0.65 per share or 42.76% thus far today.
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What We’ll Be Watching For Ahead
Moving forward, the CNA Finance team will continue to keep a close eye on VTGN. In particular, we’re interested in following the story surrounding the company’s continued work to bring AV-101 as well as the rest of its robust pipeline through development and into commercialization. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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