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, from the RESILIENT Phase 3 trial, demonstrated statistically significant reductions in weekly average pain scores at Week 14 compared to placebo (p<0.0001) in 456 fibromyalgia patients. Additionally, significant improvements were observed in sleep disturbance, fatigue, and functional outcomes.
TONMYA, a sublingual tablet administered at bedtime, was well tolerated with low discontinuation rates and primarily mild, self-limited adverse events. These results highlight its potential as a differentiated, centrally acting non-opioid treatment targeting both pain and non-restorative sleep, a common symptom in fibromyalgia.
Tonix is a fully-integrated biotechnology company with marketed products, including FDA-approved TONMYA, the first new prescription medicine for fibromyalgia in over 15 years. The company also markets Zembrace SymTouch and Tosymra for acute migraine. Its development portfolio spans CNS disorders, immunology, rare disease, and infectious disease, with candidates such as TNX-102 SL for acute stress disorder and major depressive disorder, TNX-1500 for transplant rejection, and TNX-801 for mpox and smallpox.
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