Tonix Pharmaceuticals Holding Corp (NASDAQ: TNXP) is having a relatively strong start to the trading session in the pre-market hours this morning, and for good reason. The company announced that the United States Food and Drug Administration has cleared an IND that allows for the initiation of a Phase 2 clinical study. Of course, this excited investors, sending the stock toward the top. Today, we’ll talk about:
- The news;
- what we’re seeing from TNXP as a result;
- and what we’ll be watching for ahead.
TNXP Announces FDA Clearance
As mentioned above, Tonix Pharmaceuticals Holding is having a strong start to the trading session in the pre-market hours after announcing that it has received FDA clearance. In a press release issued early this morning, the company announced that the FDA has cleared its Investigational New Drug (IND) application supporting the initiation of a Phase 2 clinical study. In the release, TNXP said that the Phase 2 study could prove to be a pivotal efficacy study of TNX-102 SL 5.6 mg as a treatment for patients with agitation in Alzheimer’s disease.
The treatment, by the brand name Tonmya®, is a treatment that has earned Breakthrough Therapy Designation from the FDA and is under multiple clinical trials. In fact that Breakthrough Therapy Designation surrounds a Phase 3 development program having to do with the use of Tonmya® for the treatment of posttraumatic stress disorder (PTSD). In a statement, Seth Lederman, M.D., President and CEO at TNXP, had the following to offer:
This potential new indication for TNX-102 SL expands our clinical development pipeline, leveraging our understanding of the TNX-102 SL mechanism of action on sleep quality and our understanding of its potential clinical benefit in patients with agitation in Alzheimer’s disease… The investigation of TNX-102 SL for agitation in Alzheimer’s disease may bring a new treatment targeting sleep disturbances in patients experiencing this condition. Currently there are no FDA-approved treatments for agitation in Alzheimer’s disease, despite a high disease burden and a need for an effective therapy. A Fast Track designation request will be filed next month to potentially accelerate the development and review of this unmet medical need.
What We’re Seeing From The Stock
One of the first lessons that we learn when we start to dabble in the market is that the news causes moves. In this particular case, the news proved to be overwhelmingly positive. After all, with the clearance to move forward with a Phase 3 program under the agitation associated with Alzheimer’s disease indication, Tonix is moving toward approval for multiple indication, which could lead to overwhelming profits from Tonmya®. So, it’s no surprise that excited investors are sending the stock toward the top. Of course, our partners at Trade Ideas were the first to alert us to the gains. At the moment (9:03), TNXP is trading at $3.25 per share after a gain of $0.13 per share or 4.17% 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 TNXP. In particular, we’re interested in follwing the story surrounding both clinical programs associated with Tonmya® and excited to watch as the company continues to pus the treatment through the development process. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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