Tonix Pharmaceuticals Reports Q1 2026 Results, TONMYA Commercial Growth and Pipeline Progress Highlighted

Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) reported its first-quarter 2026 financial results, showcasing continued commercial momentum for TONMYA, its recently launched fibromyalgia treatment, and progress across its clinical pipeline. The company noted that TONMYA, the first new fibromyalgia medicine in 15 years, has demonstrated growth in prescriptions, prescribers, refills, and patient access since its November 2025 launch. A recently announced managed care agreement is expected to expand potential coverage to approximately 35 million U.S. commercial lives, significantly broadening patient access.

In addition to commercial updates, Tonix highlighted pipeline advancements. The company reported 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. These developments underscore Tonix's commitment to addressing high unmet medical needs in central nervous system (CNS) and immunology.

Tonix Pharmaceuticals is a fully-integrated, commercial-stage biotechnology company focused on CNS and immunology treatments. TONMYA (cyclobenzaprine HCl sublingual tablets 2.8mg) is the company’s recently approved flagship medicine and the first new treatment for fibromyalgia in over 15 years. The company’s CNS commercial infrastructure also supports its marketed products for acute migraine, including Zembrace SymTouch and Tosymra. Tonix is exploring the potential of TONMYA in Phase 2 clinical trials for major depressive disorder and acute stress disorder.

Beyond TONMYA, Tonix's CNS portfolio includes TNX-2900, which is Phase 2 ready for the treatment of Prader-Willi syndrome, a rare disease. The company is also advancing a pipeline of immunology programs, including TNX-4800 for Lyme disease prophylaxis and TNX-1500, a third-generation CD40 ligand inhibitor for the prevention of kidney transplant rejection. Note that product development candidates are investigational and have not been approved for any indication.

For more information, visit the company’s newsroom at https://ibn.fm/TNXP. The full press release is available at https://ibn.fm/oVPHY.