Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) on Monday reported financial results for the third quarter ended Sept. 30, 2026, highlighted by net product revenue of approximately $17.2 million, compared with $3.3 million in the prior-year period. The revenue included $15 million from TONMYA, the company’s recently approved flagship medicine for fibromyalgia, representing a 37% increase over the second quarter.
Total prescriptions rose 28% quarter over quarter to 16,375, while new prescriptions increased 17% and refills climbed 56%. TONMYA coverage expanded to approximately 166 million lives, and the company increased its sales force to approximately 150 representatives. The prescription and coverage gains suggest growing acceptance among clinicians and payers for the first new fibromyalgia treatment in more than 15 years.
Despite the top-line growth, Tonix reported a net loss available to common stockholders of $53.3 million, or $2.89 per share, compared with a loss of $32 million, or $3.59 per share, a year earlier. The wider loss reflects increased investment in the commercial launch of TONMYA and ongoing clinical development. Tonix ended the quarter with approximately $163 million in cash and cash equivalents and expects its resources, together with approximately $1.5 million in subsequent equity financing proceeds, to fund operations into early third-quarter 2027.
The company continues to advance its clinical pipeline, including the Phase 2 HORIZON study of TNX-102 SL for major depressive disorder, the planned Phase 2 TRAIL study of TNX-4800 for Lyme disease prevention and an investigator-initiated Phase 2 study of TNX-1500 for kidney transplant rejection prevention. The latter two studies are expected to begin in the first quarter of 2027, with the TNX-4800 study pending final U.S. Food and Drug Administration agreement on its protocol.
Tonix is a fully-integrated, commercial-stage biotechnology company focused on central nervous system 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 and the first new treatment for fibromyalgia in more than 15 years. Tonix’s CNS commercial infrastructure supports its marketed products, including acute migraine products Zembrace SymTouch and Tosymra. The company is also maximizing the science behind TONMYA in Phase 2 clinical trials to evaluate its potential in major depressive disorder and acute stress disorder. Its 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 quarterly results underscore Tonix’s transition from a development-stage company to a commercial entity with a growing revenue base. The 37% sequential growth in TONMYA sales and the expansion of prescription volume indicate that the launch is gaining traction, which could bolster investor confidence in the company’s ability to fund its pipeline without near-term dilution. However, the widening net loss highlights the costs associated with building a commercial infrastructure and advancing multiple clinical programs simultaneously. For the broader biotechnology sector, Tonix’s performance may serve as a bellwether for the commercial potential of novel CNS treatments and the challenges of balancing launch execution with pipeline investment.
To view the full press release, visit https://ibn.fm/xRQdn. The latest news and updates relating to TNXP are available in the company’s newsroom at https://ibn.fm/TNXP.
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