Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP)
Shares of Tonix Pharmaceuticals Holding Corp. (NASDAQ:TONIX) closed Monday at $4.30 and have hit $6.90 in pre-market with over 1 million shares traded. The New York City-based biotechnology firm is befitting from positive reports following the receipt of the minutes of their meeting with the U.S. Food and Drug Administration (FDA). TNXP shares opened the regular trading session at $5.77 and have hit a high of $5.81 and a low of $5.01. Volumes are around 25 times that of the listed daily average.
In December of 2016, Tonix Pharmaceuticals Holding Corp. (NASDAQ:TONIX) drug candidate TNX-102 was awarded Breakthrough Therapy Designation for the treatment of posttraumatic stress disorder (PTSD). TNX-102 is being tested in a Phase 3, 12-week clinical trial labeled HONOR. HONOR is a randomized, double-blind, placebo-controlled trial with the objective of assessing the safety and efficacy profile of TNX-102. 550 patients are in the trial at 35 different U.S. locations.
Dr. Seth Lederman, President and CEO of Tonix Pharmaceuticals Holding Corp. (NASDAQ:TONIX) commented that the FDA normally requires two Phase 3 trials to succeed for a drug’s approval, however Dr. Lederman believes that a single Phase 3 study may be permitted through the Cross-Disciplinary Breakthrough Meeting held last month. At that meeting, Dr. Lederman states that the FDA was open to accelerating TNX-102 approvals if statistically persuasive topline data from the HONOR trial is evident. One of the main reasons given for a faster approval process is the lack of abuse potential emanating from the treatment.
One week ago, Tonix Pharmaceuticals Holding Corp. (NASDAQ:TONIX) shares fell on the issuance of new shares in a public offering of 1.8 million new shares of TNXP at a price of $4.45. Gross proceeds were expected at around $8.01 million and were to be used for continued development of TNX-102.
Tonix Pharmaceuticals Holding Corp. (NASDAQ:TONIX) has experienced some heavy insider trading in the form of buying. Recebly insiders have increased their positions in TNXP by almost 300%. Analysts have a consensus price target of $10 for TNXP. However, even given the price target, analysts are neutral on the shares. Only two firms follow Tonix Pharmaceuticals Holding Corp. (NASDAQ:TONIX) and both rate TNXP shares as a “Hold”.
I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 96 hours. All information, or data, is provided with no guarantees of accuracy.
About the author: Marc has a degree in economics and a MSc. in Finance. Over his 20-year career, Marc has worked for global investment firms in Europe and the United States as an analyst, fund manager, and consultant.