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Tonix Pharmaceuticals Announces Presentation at the A.G.P. Annual Healthcare Company Showcase
GlobeNewswire News Room· 2025-05-22 11:00
Company Overview - Tonix Pharmaceuticals Holding Corp. is a fully-integrated biotechnology company focused on pain management therapies and vaccines for public health challenges [2] - The company has a development portfolio primarily targeting central nervous system (CNS) disorders [2] Product Development - Tonix's lead product candidate, TNX-102 SL, is aimed at managing fibromyalgia, with an NDA submitted based on two statistically significant Phase 3 studies [2] - The FDA has assigned a PDUFA goal date of August 15, 2025, for a decision on marketing authorization for TNX-102 SL, which has also received Fast Track designation [2] - TNX-102 SL is additionally being developed for acute stress reaction and acute stress disorder under a Physician-Initiated IND at the University of North Carolina [2] Immunology and Infectious Disease Portfolio - The immunology portfolio includes TNX-1500, a monoclonal antibody targeting CD40-ligand for preventing allograft rejection and treating autoimmune diseases [2] - The infectious disease portfolio features TNX-801, a vaccine for mpox and smallpox, and TNX-4200, a broad-spectrum antiviral agent with a contract worth up to $34 million over five years with the U.S. Department of Defense [2] Commercial Products - Tonix Medicines, the commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) and Tosymra® (sumatriptan nasal spray) for treating acute migraine in adults [2][5]