Breakthrough Therapy Designation in PTSD
Tonix has announced that it has been granted Breakthrough Therapy Designation (BTD) by the FDA as its Phase II AtEase data for TNX-102 SL in military-related PTSD indicate the drug may successfully treat a serious condition, a key requirement for BTD. Key benefits of BTD are intensive guidance from the FDA on the drug development program, an organizational commitment involving senior managers at the FDA, and the submission of portions of the NDA on a rolling basis.Tonix Pharmaceuticals Holding is a clinical-stage biopharmaceutical company focused on discovering and developing pharmaceutical products to treat serious neuropsychiatric conditions and to improve biodefense through the development of potential medical counter-measures. The company's main drug development program is focused on delivering a long-term treatment for posttraumatic stress disorder. The company's primary product candidate, Tonmya, or TNX-102 SL, is a proprietary low-dose cyclobenzaprine sublingual tablet, designed for bedtime administration. TNX-102 SL is also being developed as a treatment for agitation in Alzheimer's disease.
Edison is an investment research and advisory company, with offices in North America, Europe, the Middle East and AsiaPac. The heart of Edison is our world renowned equity research platform and deep multi-sector expertise. At Edison Investment Research, our research is widely read by international investors, advisors and stakeholders. Edison Advisors leverages our core research platform to provide differentiated services including investor relations and strategic consulting.
.
Unfortunately, this report is not available for the investor type or country you selected.
Browse all ResearchPool reportsReport is subscription only.
Thank you, your report is ready.
Thank you, your report is ready.