Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) announced it will present real-world data on fibromyalgia treatment at the upcoming ISPOR 2026 conference. The poster presentation will feature findings from a retrospective cohort study analyzing U.S. claims data from adults with fibromyalgia between April 2021 and April 2024. This research comes after the FDA approval of TONMYA (cyclobenzaprine HCl sublingual tablets 2.8 mg) in August 2025 and its U.S. commercial launch in November 2025, marking the first new treatment for fibromyalgia in more than 15 years.
The study aims to provide insights into current treatment patterns and unmet needs in fibromyalgia management, using real-world evidence from a large claims database. By examining data from the pre-TONMYA era, the research establishes a baseline for understanding how the introduction of this novel therapy may shift treatment paradigms. Fibromyalgia affects an estimated 4 million adults in the United States, and until TONMYA’s approval, treatment options had been limited to a few medications repurposed from other conditions.
Tonix Pharmaceuticals is a fully integrated commercial-stage biotechnology company focused on central nervous system (CNS) and immunology treatments in areas of high unmet medical need. The company’s CNS commercial infrastructure supports its marketed products, including acute migraine treatments Zembrace SymTouch and Tosymra. Beyond fibromyalgia, Tonix is maximizing the science behind TONMYA in Phase 2 clinical trials evaluating its potential in major depressive disorder and acute stress disorder. Additionally, the company’s CNS pipeline includes TNX-2900, which is Phase 2 ready for Prader-Willi syndrome, a rare disease.
The company is also advancing a pipeline of immunology programs, including monoclonal antibody TNX-4800 for Lyme disease prophylaxis and TNX-1500, a third-generation CD40 ligand inhibitor for the prevention of kidney transplant rejection. These programs highlight Tonix’s broader strategy to address conditions with significant unmet medical needs across both CNS and immunology.
The ISPOR 2026 presentation underscores the importance of real-world evidence in understanding how new therapies like TONMYA fit into existing treatment landscapes. For investors and healthcare professionals, the data will offer valuable insights into disease burden and treatment patterns, potentially informing future clinical and commercial strategies. More information about Tonix and its pipeline is available in the company’s newsroom at https://ibn.fm/TNXP.
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 full press release can be viewed at https://ibn.fm/A3668.
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