Tonix Pharmaceuticals (NASDAQ: TNXP), a fully integrated commercial biotechnology company, reported financial results for the fourth quarter and full year ended Dec. 31, 2025, highlighting the U.S. launch of TONMYA(TM), 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. Tonix 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, while ending the year with approximately $207.6 million in cash and cash equivalents to support operations into the first quarter of 2027.
To view the full press release, visit https://ibn.fm/U3juw
Tonix Pharmaceuticals Holding Corp.*
Tonix Pharmaceuticals is a fully-integrated, commercial-stage biotechnology company focused on central nervous system (CNS) and immunology treatments in areas of high unmet medical need. TONMYA(TM) (cyclobenzaprine HCl sublingual tablets 2.8mg), the Company’s recently approved flagship medicine, is the first new treatment for fibromyalgia in more than 15 years. Tonix’s CNS commercial infrastructure supports its marketed products, including its acute migraine products, Zembrace(R) SymTouch(R) and Tosymra(R). 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.
* Tonix’s product development candidates are investigational new drugs or biologics; their efficacy and safety have not been established and have not been approved for any indication.
NOTE TO INVESTORS: The latest news and updates relating to TNXP are available in the company’s newsroom at https://ibn.fm/TNXP
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