Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) announced the presentation of clinical data for TONMYA (formerly TNX-102 SL) at the 2026 Non-Opioid Pain Therapeutics Summit held Jan. 29, 2026, in Boston. The data, drawn from the RESILIENT Phase 3 trial, underscore the therapeutic potential of this first-in-class non-opioid analgesic for fibromyalgia, a chronic pain condition affecting millions of adults.
The RESILIENT study was a 14-week randomized, double-blind, placebo-controlled trial involving 456 patients with fibromyalgia. Results showed 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). Additionally, patients experienced significant improvements in sleep disturbance, fatigue, and functional outcomes. The treatment was well tolerated, with low discontinuation rates and primarily mild, self-limited adverse events.
TONMYA is the first new prescription medicine approved by the FDA for fibromyalgia in more than 15 years. Tonix markets TONMYA along with two treatments for acute migraine in adults: Zembrace SymTouch (sumatriptan injection) and Tosymra (sumatriptan nasal spray). The company's development portfolio focuses on central nervous system disorders, immunology, immuno-oncology, rare disease, and infectious disease.
Tonix is also developing TNX-102 SL 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 is developing 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 long-acting humanized monoclonal antibody for the seasonal prevention of Lyme disease. TNX-4200, a broad-spectrum antiviral agent targeting CD45, is being developed under a contract with the U.S. DoD's Defense Threat Reduction Agency for up to $34 million over five years.
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