Tonix Pharmaceuticals Further Strengthens Commercial Leadership Team with Appointment of Gary Ainsworth as Vice President of Market Access

Company Updates - Tonix Pharmaceuticals appointed Gary Ainsworth as Vice President, Market Access, effective immediately Mr Ainsworth brings over two decades of industry and market access experience, including leadership roles at Eversana Intouch, Havas Gemini, Baxter International, Roche Laboratories, and Sanofi predecessor companies [1][2] - The U S Food and Drug Administration (FDA) assigned a Prescription Drug User Fee Act (PDUFA) goal date of August 15, 2025, for marketing authorization of TNX-102 SL for fibromyalgia management TNX-102 SL is a non-opioid, centrally-acting analgesic targeting a chronic pain condition that predominantly affects women [1][3] Product Pipeline - Tonix's development portfolio focuses on central nervous system (CNS) disorders, with TNX-102 SL as a priority candidate for fibromyalgia management The product candidate has completed two statistically significant Phase 3 studies and received FDA Fast Track designation [4] - The company is developing TNX-1300 (cocaine esterase) for cocaine intoxication, which has FDA Breakthrough Therapy designation and is supported by a grant from the U S National Institute of Drug Abuse and Addiction [4] - Tonix's immunology portfolio includes TNX-1500, an Fc-modified humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) for preventing allograft rejection and treating autoimmune diseases [5] - The company is advancing TNX-2900 for Prader-Willi syndrome and TNX-801, a vaccine for mpox Additionally, Tonix secured a $34 million contract with the U S DoD's Defense Threat Reduction Agency (DTRA) to develop TNX-4200, a small molecule broad-spectrum antiviral agent targeting CD45 [5] Commercial Operations - Tonix Medicines, the company's commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg for acute migraine treatment in adults [5] - The company operates a state-of-the-art infectious disease research facility in Frederick, Md [5]