Tonix Pharmaceuticals Secures GPO Agreement Covering 35 Million Lives for TONMYA, Expanding Access to Non-Opioid Fibromyalgia Treatment

Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) has announced a new agreement with a leading group purchasing organization (GPO) that will provide coverage for its FDA-approved fibromyalgia treatment, TONMYA (cyclobenzaprine HCl sublingual tablets), to approximately 35 million U.S. commercial lives. The agreement, effective May 1, 2026, covers about 20% of the commercial market under standard utilization management criteria, according to a press release.

This development is a key milestone for Tonix as it seeks to broaden patient access to TONMYA, which was approved by the FDA as the first new treatment for fibromyalgia in more than 15 years. The company is actively pursuing additional coverage across both commercial and government channels. Currently, TONMYA has existing Medicaid coverage in 38 states, representing approximately 55 million lives.

The GPO agreement is expected to enhance the commercial viability of TONMYA, a non-opioid alternative for managing fibromyalgia, a chronic condition characterized by widespread pain, fatigue, and cognitive difficulties. By securing coverage for a substantial portion of the insured population, Tonix aims to facilitate patient access and potentially drive adoption among healthcare providers.

Tonix Pharmaceuticals is a fully-integrated, commercial-stage biotechnology company with a focus on central nervous system (CNS) and immunology treatments. The company's CNS commercial infrastructure supports its marketed products, including acute migraine treatments Zembrace SymTouch and Tosymra. Additionally, Tonix is exploring the potential of TONMYA in Phase 2 clinical trials for major depressive disorder and acute stress disorder.

The company's pipeline also includes TNX-2900, which is Phase 2 ready for Prader-Willi syndrome, and immunology programs such as monoclonal antibody TNX-4800 for Lyme disease prophylaxis and TNX-1500, a third-generation CD40 ligand inhibitor for preventing kidney transplant rejection. It is important to note that these product development candidates are investigational and have not been approved for any indication.

Investors can find the latest news and updates related to TNXP in the company's newsroom at https://ibn.fm/TNXP. For more details on the GPO agreement, the full press release is available at https://ibn.fm/ShicX.

This announcement underscores Tonix's commitment to expanding access to innovative therapies for conditions with high unmet medical needs, particularly in the CNS space. The GPO agreement represents a strategic advancement in the company's commercialization efforts for TONMYA, potentially positioning it as a key player in the fibromyalgia treatment landscape.