Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) announced second-quarter 2026 net product revenue of approximately $13.5 million, a substantial increase from $2 million in the same period last year. The growth was primarily driven by approximately $11 million in net sales of TONMYA, its recently approved treatment for fibromyalgia. TONMYA recorded 12,592 total prescriptions during the quarter, up 100% sequentially, with new patient prescriptions increasing 36% and refills surging 207%.
The company highlighted that TONMYA currently has coverage representing approximately 136 million lives across commercial, managed Medicare, and Medicaid channels. With a managed Medicare agreement set to take effect on Jan. 1, 2027, coverage is expected to expand to approximately 145 million lives, broadening patient access to this novel therapy.
In addition to commercial progress, Tonix continues to advance its clinical pipeline. The company enrolled the first patient in the potentially pivotal Phase 2 HORIZON study of TNX-102 SL for major depressive disorder. Furthermore, Tonix is preparing to initiate an adaptive Phase 2 field study of TNX-4800 for Lyme disease prevention in the first quarter of 2027, pending final FDA review and agreement on the protocol.
Financially, Tonix ended the quarter with approximately $176.2 million in cash and cash equivalents. The company stated that its resources, together with third-quarter equity proceeds to date, are expected to fund planned operations and capital expenditures into early second-quarter 2027.
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 first new treatment for fibromyalgia in more than 15 years. 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.
The company's CNS portfolio also includes TNX-2900, which is Phase 2 ready for the treatment of Prader-Willi syndrome, a rare disease. In immunology, Tonix is advancing TNX-4800, a monoclonal antibody for Lyme disease prophylaxis, and TNX-1500, a third-generation CD40 ligand inhibitor for the prevention of kidney transplant rejection.
The significant revenue growth and pipeline advancements underscore Tonix's transition into a commercial-stage biotech with a promising future. The expansion of TONMYA's coverage and the progress in clinical trials indicate potential impacts on patients with fibromyalgia, major depressive disorder, and Lyme disease, as well as on the broader CNS and immunology therapeutic markets.
For more details, the full press release is available at https://ibn.fm/6Yytj. Latest news and updates regarding TNXP can be found in the company's newsroom at https://ibn.fm/TNXP.
