Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) reported first-quarter 2026 financial results while highlighting continued commercial momentum for TONMYA, its recently launched fibromyalgia treatment, and advancement across its clinical pipeline. The company said TONMYA, the first new fibromyalgia medicine in 15 years, has shown growth in prescriptions, prescribers, refills and patient access since its November 2025 launch. A recently announced managed care agreement is expanding potential coverage to approximately 35 million U.S. commercial lives.
Pipeline progress included positive Phase 1 data for TNX-4800, a Lyme disease prevention candidate, and plans to begin a Phase 2 study of TONMYA in major depressive disorder later this year. 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 (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 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. To view the full press release, visit https://ibn.fm/oVPHY.