Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) investors have a smile on their faces Tuesday morning, after the drug maker announced the receipt of official minutes from its Initial Cross-Disciplinary Breakthrough Meeting held with the FDA on March 9, 2017. Upon being awarded Breakthrough Therapy designation in December 2016, Tonix was invited to meet with the FDA to evaluate the feasibility of accelerating the development and registration of TNX-102 SL* for the treatment of posttraumatic stress disorder (PTSD).
With the official minutes from the FDA now in hand, the company believes that it has a path forward for a possible submission of the TNX-102 SL NDA, sending shares rising nearly 18% in early trading Tuesday.
Seth Lederman, M.D., president and chief executive officer of Tonix, stated, “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.”
On the ratings front, Tonix Pharmaceuticals has been the subject of a number of recent research reports. In a report issued on March 7, Roth Capital analyst Scott Henry reiterated a Hold rating on TNXP, with a price target of $6.00, which implies an upside of 40% from current levels. Separately, on December 30, Oppenheimer’s Jay Olson reiterated a Hold rating on the stock.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Scott Henry and Jay Olson have a yearly average loss of 2.2% and a return of 4.2% respectively. Henry has a success rate of 39% and is ranked #4054 out of 4560 analysts, while Olson has a success rate of 49% and is ranked #1774.
Tonix Pharmaceuticals Holding Corp. is a clinical-stage pharmaceutical company. It engages in developing and manufacturing new pharmaceutical products that are used in central nervous system drugs in large and growing markets. It products include TNX-102 SL and TNX-201.