Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) announced the presentation of clinical data for TONMYA (previously investigated as TNX-102 SL) at the 2026 Non-Opioid Pain Therapeutics Summit held Jan. 29, 2026, in Boston. The data were drawn from the RESILIENT trial, a 14-week Phase 3 randomized, double-blind, placebo-controlled study involving 456 patients with fibromyalgia. The study demonstrated that bedtime sublingual administration of TONMYA led to a statistically significant reduction in weekly average pain scores at Week 14 compared to placebo (p<0.0001), along with significant improvements in sleep disturbance, fatigue, and functional outcomes.
According to the press release, TONMYA was well tolerated, with low discontinuation rates and primarily mild, self-limited adverse events. These results support its potential as a differentiated, centrally acting non-opioid treatment designed to address both pain and non-restorative sleep in fibromyalgia patients. The full press release is available at https://ibn.fm/VizLh.
Tonix is a fully-integrated biotechnology company with marketed products and a pipeline of development candidates. The company markets FDA-approved TONMYA, a first-in-class non-opioid analgesic for fibromyalgia, which is the first new prescription medicine approved by the FDA for this condition in more than 15 years. Tonix also markets two treatments for acute migraine in adults: Zembrace SymTouch (sumatriptan injection) and Tosymra (sumatriptan nasal spray).
The development portfolio focuses on central nervous system disorders, immunology, immuno-oncology, rare disease, and infectious disease. TNX-102 SL is being developed for acute stress reaction and acute stress disorder under an Investigator-Initiated IND at the University of North Carolina in the OASIS study funded by the U.S. Department of Defense. Additionally, TNX-102 SL is in development for major depressive disorder. The immunology portfolio includes TNX-1500, a Phase 2-ready Fc-modified humanized monoclonal antibody targeting CD40-ligand for prevention of allograft rejection and treatment of autoimmune diseases.
In rare disease, Tonix's portfolio includes TNX-2900 (intranasal oxytocin potentiated with magnesium) for Prader-Willi syndrome, expected to start a potential pivotal Phase 2 study in 2026. The infectious disease portfolio includes TNX-801, a vaccine for mpox and smallpox, and TNX-4800, a Phase 2-ready long-acting humanized monoclonal antibody for seasonal prevention of Lyme disease. Additionally, TNX-4200, under a contract with the U.S. Department of Defense's Defense Threat Reduction Agency for up to $34 million over five years, is a small molecule broad-spectrum antiviral agent targeting CD45 for high lethality infections.
Tonix owns and operates a state-of-the-art infectious disease research facility in Frederick, Md. The company's 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. For the latest news and updates relating to TNXP, visit the company's newsroom at https://ibn.fm/TNXP.
