Tonix Pharmaceuticals (NASDAQ: TNXP) is having an incredibly strong start to the trading session this morning, and for good reason. The company announced that it has received the official minutes from an FDA meeting and provided an update with regard to clinical development. Of course, the news excited investors, sending the stock on a run for the top. Today, we’ll talk about:
- The clinical news;
- what we’re seeing from the stock; and
- what we’ll be watching for ahead.
TNXP Heads Up On Clinical News
As mentioned above, Tonix Pharmaceuticals is having an incredibly strong start to the trading session this morning after announcing clinical news. In a press release issued early this morning, the company said that it received the official minutes from the October 29th Breakthrough Thearpy Type B Clinical Guidance meeting with the FDA. The company said that the minutes are consistent with the preliminary guidance the company received from the FDA. The minutes also confirm the FDA’s acceptance of its Phase 3 “RECOVERY” trial design.
With the news in mind, TNXP said that it plans to start the RECOVERY trial in the first quarter of 2019. During the trial, the company will assess Tonmya as a treatment for posttraumatic stress disorder (PTSD).
In the release, the company said that th enew trial will come with several new design features. These include restricting enrollment of study participants to individuals with PTSD who experienced an index trauma within nine years of screening. TNXP said that the trial will also include participants who have experienced civilian traumas, rather than just assessing the treatment among military-related traumas.
In the release, the company said that the primary endpoint on the trial is mean change from baseline in the severity of PTSD symptoms as measured by the Clinitian Administered PTSD Scale. In a statement, Seth Lederman, M.D., President and CEO at TNXP, had the following to offer:
The minutes from our Breakthrough Therapy Clinical Guidance meeting with the FDA are consistent with our previous assessment. We are moving forward expeditiously to initiate the RECOVERY study in the first quarter of 2019 and expect to have topline data in the first half of 2020.
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 Tonix Pharmaceuticals, the news proved to be overwhelmingly positive. After all, the meeting minutes confirm the acceptance of the Phase 3 trial design, meaning that the company now has regulatory approval to move forward with the trial and bringing it one step closer to bringing Tonmya to market. So, it comes as no surprise to see that excited investors are pushing the stock on a run for the top. As is normally the case, our partners at Trade Ideas were the first to alert us to the gains. Currently (8:34), TNXP is trading at $7.40 per share after a gain of $3.60 per share or 94.74% thus far today.
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What We’ll Be Watching For Ahead
Moving forward, the iWatch Markets team will continue to keep a close eye on TNXP. In particular, we’re interested in following the story surrounding the company’s continued work to bring Tonmya to market. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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