Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) announced its first-quarter 2026 financial results, emphasizing the continued commercial momentum of TONMYA, its recently launched fibromyalgia treatment, and advancements across its clinical pipeline. TONMYA, the first new fibromyalgia medicine in 15 years, has demonstrated growth in prescriptions, prescribers, refills, and patient access since its November 2025 launch. The company also noted a recently announced managed care agreement that expands potential coverage to approximately 35 million U.S. commercial lives.
Pipeline progress includes positive Phase 1 data for TNX-4800, a Lyme disease prevention candidate, and plans to initiate 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) is the company’s recently approved flagship medicine.
Tonix’s CNS commercial infrastructure also supports its acute migraine products, Zembrace SymTouch and Tosymra. The company is maximizing the science behind TONMYA through Phase 2 clinical trials evaluating its potential in major depressive disorder and acute stress disorder. Additionally, Tonix’s CNS portfolio includes TNX-2900, which is Phase 2 ready for the treatment of Prader-Willi syndrome, a rare disease.
In immunology, Tonix is advancing a pipeline 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. All 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.
The full press release is available at https://ibn.fm/oVPHY. For the latest news and updates regarding TNXP, visit the company’s newsroom at https://ibn.fm/TNXP.
