Tonix Pharmaceuticals Announces Poster Presentation at the American College of Rheumatology (ACR) Convergence 2024 Annual Meeting

Core Insights - Tonix Pharmaceuticals Holding Corp. announced a poster presentation by CEO Seth Lederman at the ACR Convergence 2024 Annual Meeting, focusing on a Phase 3 trial of TNX-102 SL for fibromyalgia [1][2] Company Overview - Tonix Pharmaceuticals is a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, primarily targeting central nervous system (CNS) disorders [2] - The company is advancing TNX-102 SL, a product candidate for fibromyalgia management, for which an NDA was submitted based on two statistically significant Phase 3 studies [2] - The FDA has granted Fast Track designation to TNX-102 SL, with an expected decision on NDA acceptance in December 2024 and a potential approval decision in 2025 [2] Product Development - TNX-102 SL is also being developed for acute stress reaction and acute stress disorder under a Physician-Initiated IND at the University of North Carolina [2] - Tonix's CNS portfolio includes TNX-1300, a biologic in Phase 2 development for cocaine intoxication, which has received FDA Breakthrough Therapy designation [2] - The immunology portfolio includes TNX-1500, targeting CD40-ligand for organ transplant rejection and autoimmune diseases [2] - Tonix is developing TNX-2900 for Prader-Willi syndrome and a vaccine for mpox, TNX-801 [2] - The company has secured a contract with the U.S. DoD for up to $34 million over five years to develop TNX-4200, targeting CD45 for infection prevention in military personnel [2] Commercial Products - Tonix Medicines, the commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) and Tosymra® (sumatriptan nasal spray) for acute migraine treatment [2]