Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) is having an incredible time in the pre-market hours this morning, and for good reason. The company recently completed a meeting with the FDA, the results of which are proving to be overwhelmingly exciting to investors. As a result, the stock shot upward, prompting our partners at Trade Ideas to send the alert. At the moment (8:27), TNXP is trading at $5.96 per share after a pre-market gain of $1.66 per share (38.60%) thus far today.
TNXP Announces Results Of A Positive FDA Meeting
As mentioned above, Tonix Pharmaceuticals is having a strong morning in the market this morning after announcing positive FDA news. The company announced the receipt of official minutes from its Initial Cross-Disciplinary Breakthrough Meeting with the FDA that was held on March 9th. Along with being awarded Breakthrough Therapy designation, TNXP was invited to meet with the FDA to evaluate the feasibility of speeding up the process with regard to the development and registration of TNX-102 SL, which is designed for the treatment of PTSD. In a statement, Seth Lederman, M.D., President and CEO at TNXP, had the following to offer:
“The FDA’s consideration of a single-study New Drug Application (NDA) and continued support of the Phase 3 HONOR study are critical to accelerating the availability of a potentially improved treatment option for PTSD patients, especially those patients with military-related PTSD. The FDA’s standard of evidence for drug approval typically requires two positive Phase 3 trials; however, following our Initial Cross-Disciplinary Breakthrough Meeting in March, the FDA confirmed a single-study NDA approval could be possible based on statistically persuasive topline data from the ongoing HONOR study. Additionally, due to the lack of evidence of potential abuse in clinical studies of TNX-102 SL, the FDA agreed that studies in assessing abuse potential of TNX-102 SL are not required to support the TNX-102 SL NDA.”
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What We’ll Be Watching For Ahead
Moving forward, the CNA Finance team will be keeping a close eye on TNXP. In particular, we’re interested in following the company through the development of TNX-102 SL. We’ll continue to follow the news closely and bring it to you as it breaks!
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