Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) presented clinical data for TONMYA, previously investigated as TNX-102 SL, at the 2026 Non-Opioid Pain Therapeutics Summit held Jan. 29, 2026, in Boston. The data were drawn from RESILIENT, a 14-week Phase 3 randomized, double-blind, placebo-controlled trial involving 456 patients with fibromyalgia. Bedtime sublingual administration of TONMYA demonstrated a statistically significant reduction in weekly average pain scores at Week 14 versus placebo (p<0.0001), along with significant improvements in sleep disturbance, fatigue, and functional outcomes.
Tonix reported that 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 pipeline of development candidates. The company markets FDA-approved TONMYA, a first-in-class, non-opioid analgesic medicine for the treatment of fibromyalgia, a chronic pain condition that affects millions of adults. TONMYA is the first new prescription medicine approved by the FDA for fibromyalgia 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 is focused on central nervous system (CNS) disorders, immunology, immuno-oncology, rare disease and infectious disease. TNX-102 SL is being developed to treat 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). TNX-102 SL is also in development for major depressive disorder. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a Phase 2-ready Fc-modified humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases.
Tonix’s rare disease portfolio includes TNX-2900, intranasal oxytocin potentiated with magnesium, in development for Prader-Willi syndrome and expected to start a potential pivotal Phase 2 study in 2026. Tonix’s infectious disease portfolio includes TNX-801, a vaccine in development for mpox and smallpox, as well as TNX-4800, a Phase 2-ready long-acting humanized monoclonal antibody for the seasonal prevention of Lyme disease. Finally, TNX-4200 for which Tonix has a contract with the U.S. DoD’s Defense Threat Reduction Agency (DTRA) for up to $34 million over five years, is a small molecule broad-spectrum antiviral agent targeting CD45 for the prevention or treatment of high lethality infections to improve the medical readiness of military personnel in biological threat environments. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, Md.
Tonix’s product development candidates are investigational new drugs or biologics; their efficacy and safety have not been established and have not been approved for any indication. The latest news and updates relating to TNXP are available in the company’s newsroom at https://ibn.fm/TNXP.
