Tonix Pharmaceuticals Reports 2025 Financial Results and Highlights TONMYA Launch for Fibromyalgia

Tonix Pharmaceuticals Holding Corp. reported financial results for the fourth quarter and full year ended Dec. 31, 2025, highlighting the U.S. launch of TONMYA, the first new medicine approved for fibromyalgia in more than 15 years. The product, approved by the U.S. Food and Drug Administration in August 2025, became commercially available by prescription on Nov. 17, 2025, and early launch metrics indicate growing prescriber uptake, with more than 1,500 healthcare providers prescribing the therapy and approximately 2,500 patients initiating treatment. This launch represents a significant advancement for a patient population that has seen limited new therapeutic options for over a decade and a half.

The company also advanced several pipeline programs during the year, including in-licensing TNX-4800 for the seasonal prevention of Lyme disease, receiving Investigational New Drug clearance for the HORIZON Phase 2 study of TNX-102 SL for major depressive disorder and progressing development across its immunology and rare disease programs. Tonix ended the year with approximately $207.6 million in cash and cash equivalents to support operations into the first quarter of 2027, providing financial stability for continued development. The company's CNS commercial infrastructure supports its marketed products, including its acute migraine products, Zembrace SymTouch and Tosymra.

Tonix is maximizing the science behind TONMYA in Phase 2 clinical trials to evaluate its potential in major depressive disorder and acute stress disorder. In addition, the company's CNS portfolio includes TNX-2900, which is Phase 2 ready for the treatment of Prader-Willi syndrome, a rare disease. Tonix is also advancing a pipeline of immunology programs, including monoclonal antibody TNX-4800 for Lyme disease prophylaxis and TNX-1500, a third-generation CD40 ligand inhibitor for the prevention of kidney transplant rejection. The latest news and updates relating to TNXP are available in the company's newsroom at https://ibn.fm/TNXP.

This announcement matters because it demonstrates Tonix's transition to a commercial-stage biotechnology company with a successfully launched product addressing a significant unmet medical need in fibromyalgia. The early adoption metrics suggest strong physician and patient interest in TONMYA, potentially establishing a new standard of care for a condition affecting millions of Americans. Furthermore, the company's robust pipeline across central nervous system disorders and immunology indicates a diversified approach to addressing complex medical challenges. The financial position provides runway for continued research and development activities through early 2027, supporting the advancement of multiple clinical programs that could yield additional therapeutic options for patients with limited treatment alternatives.