Core Insights - Tonix Pharmaceuticals has received FDA approval for Tonmya™, the first new therapy for fibromyalgia in over 15 years, with a U.S. launch expected in Q4 2025 [1][4]. Company Overview - Tonix Pharmaceuticals is a fully-integrated biotechnology company with marketed products and a pipeline of development candidates [2][4]. - The company focuses on central nervous system disorders, immunology, immuno-oncology, rare diseases, and infectious diseases [4]. Leadership Appointment - Ganesh Kamath has been appointed as Head of Market Access, effective September 29, 2025, bringing over 25 years of experience in market access, pricing, and commercial operations [2][3]. - Kamath's previous roles include Vice President at CuriaGlobal and CFO at Hutchmed International, where he established pricing governance frameworks and advanced market access strategies [3]. Product Details - Tonmya™ is indicated for the treatment of fibromyalgia in adults and is a first-in-class, non-opioid analgesic [4][7]. - The product is part of a broader portfolio that includes treatments for acute migraine and various CNS disorders [4]. Development Pipeline - Tonix's development pipeline includes TNX-102 SL for acute stress reaction, TNX-1500 for organ transplant rejection, TNX-2900 for Prader-Willi syndrome, and TNX-801 for mpox and smallpox [4]. - The company has a contract with the U.S. Department of Defense for TNX-4200, a broad-spectrum antiviral agent, valued at up to $34 million over five years [4].
Tonix Pharmaceuticals Further Strengthens Commercial Leadership Team with Appointment of Ganesh Kamath as Head of Market Access