Tonix Pharmaceuticals Holding Corp (TNXP)

[avinanyc]

TNX-102 SL, as a bedtime treatment for agitation in Alzheimer’s disease, received Investigational New Drug (IND) clearance in May 2018. Fast Track designation was granted by the FDA in July. Fast track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. It reflects the recognition by the FDA that TNX-102 SL has the potential to address a large unmet medical need for a serious condition. A Phase 2, potential pivotal, efficacy study protocol submitted in July 2018 is pending FDA review and acceptance.