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, demonstrated 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 enrolled 456 patients with fibromyalgia and also showed significant improvements in sleep disturbance, fatigue, and functional outcomes.
TONMYA was well tolerated, with low discontinuation rates and primarily mild, self-limited adverse events. These findings 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 development pipeline. 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 over 15 years. Tonix also markets Zembrace SymTouch and Tosymra for acute migraine in adults.
The development portfolio includes 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 (DoD), and 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.
Rare disease candidates include 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 (vaccine for mpox and smallpox), TNX-4800 (long-acting humanized monoclonal antibody for Lyme disease prevention), and TNX-4200, a broad-spectrum antiviral agent under a contract with the U.S. DoD’s Defense Threat Reduction Agency (DTRA) for up to $34 million over five years.
For more information on Tonix, visit https://ibn.fm/TNXP.
