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].

Core Insights - Tonmya is the first FDA-approved therapy for fibromyalgia in over 15 years, representing a significant advancement for the treatment of this chronic pain condition affecting over 10 million adults in the U.S. [1][2] - The approval of Tonmya was based on two pivotal Phase 3 clinical trials that demonstrated its efficacy in significantly reducing fibromyalgia pain compared to placebo [2][10] - Tonmya is expected to be commercially available in the fourth quarter of 2025 [1][6] Company Overview - Tonix Pharmaceuticals Holding Corp. is a fully-integrated biotechnology company focused on developing treatments for central nervous system disorders, immunology, immuno-oncology, and infectious diseases [12][13] - The company has a proprietary formulation for Tonmya, which is a sublingual tablet designed for rapid absorption and reduced production of long half-life metabolites [9] Industry Context - Fibromyalgia is a chronic pain disorder that affects an estimated 10 million adults in the U.S., with approximately 80% being women. It is characterized by chronic widespread pain, fatigue, and sleep disturbances [8] - The chronic pain associated with fibromyalgia significantly disrupts patients' daily lives and is often inadequately managed due to a lack of effective treatment options [4][8]