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) in 456 patients with fibromyalgia. The study 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, supporting its potential as a differentiated, centrally acting non-opioid treatment for fibromyalgia that addresses both pain and non-restorative sleep.
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, marking the first new prescription medicine approved by the FDA for this condition in over 15 years. Additionally, Tonix markets Zembrace SymTouch and Tosymra for acute migraine in adults. The company's development portfolio focuses on central nervous system disorders, immunology, immuno-oncology, rare disease, and infectious disease. Notable pipeline candidates include TNX-102 SL for acute stress reaction and major depressive disorder, TNX-1500 for prevention of allograft rejection and autoimmune diseases, TNX-2900 for Prader-Willi syndrome, TNX-801 for mpox and smallpox, and TNX-4800 for Lyme disease prevention. Tonix also has a contract with the U.S. Department of Defense's Defense Threat Reduction Agency for up to $34 million over five years to develop TNX-4200, a broad-spectrum antiviral agent.
The full press release is available at https://ibn.fm/VizLh. For more information on Tonix, visit their newsroom at https://ibn.fm/TNXP.
