Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) presented clinical data for TONMYA (TM), previously investigated as TNX-102 SL, at the 2026 Non-Opioid Pain Therapeutics Summit held January 29, 2026, in Boston. The data from the RESILIENT Phase 3 trial demonstrated 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.
The RESILIENT trial was a 14-week randomized, double-blind, placebo-controlled study involving 456 patients with fibromyalgia. Bedtime sublingual administration of TONMYA showed that the drug was well tolerated, with low discontinuation rates and primarily mild, self-limited adverse events. These results support TONMYA's potential as a differentiated, centrally acting non-opioid treatment that addresses both pain and non-restorative sleep in fibromyalgia patients.
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).
Tonix's 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. TNX-102 SL is also in development for major depressive disorder.
In immunology, Tonix's 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. The rare disease portfolio includes TNX-2900, intranasal oxytocin potentiated with magnesium 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 agent under a contract with the U.S. DoD's Defense Threat Reduction Agency.
For more information, visit the company's newsroom at https://ibn.fm/TNXP.
