Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) presented clinical data for TONMYA (previously TNX-102 SL) at the 2026 Non-Opioid Pain Therapeutics Summit in Boston on January 29, 2026. The data, drawn from the RESILIENT Phase 3 trial, showed statistically significant reductions in weekly average pain scores at Week 14 compared to placebo (p<0.0001). The 14-week randomized, double-blind, placebo-controlled study involved 456 patients with fibromyalgia. Bedtime sublingual administration of TONMYA also demonstrated significant improvements in sleep disturbance, fatigue, and functional outcomes.
TONMYA was well tolerated, with low discontinuation rates and primarily mild, self-limited adverse events. The results support its potential as a differentiated, centrally acting non-opioid treatment designed to address both pain and non-restorative sleep in fibromyalgia patients. For full details, visit https://ibn.fm/VizLh.
Tonix is a fully-integrated biotechnology company with marketed products and a pipeline of development candidates. TONMYA is FDA-approved as a first-in-class, non-opioid analgesic for fibromyalgia, the first new prescription medicine approved for this condition in over 15 years. Tonix also markets Zembrace SymTouch and Tosymra for acute migraine. The company's development portfolio focuses on CNS 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, funded by the U.S. Department of Defense, and also for major depressive disorder.
Tonix's immunology portfolio includes TNX-1500, a Phase 2-ready monoclonal antibody targeting CD40-ligand for allograft rejection and autoimmune diseases. Its rare disease portfolio includes TNX-2900 (intranasal oxytocin) for Prader-Willi syndrome, expected to start a potential pivotal Phase 2 study in 2026. Infectious disease candidates include TNX-801 for mpox and smallpox, TNX-4800 for Lyme disease prevention, and TNX-4200, a broad-spectrum antiviral under a DTRA contract. Tonix operates an infectious disease research facility in Frederick, Md. Note that development candidates are investigational and not approved. For updates, visit https://ibn.fm/TNXP.
