Tonix Pharmaceuticals Holding Corp.

Tonix Pharmaceuticals announced a new agreement with a pharmacy benefit manager to provide coverage for TONMYA to approximately 9 million Medicare Part D beneficiaries, effective January 1, 2027. This expands TONMYA's total expected coverage to 145 million individuals, or 46% of all covered lives in the U.S., by early 2027. Following these coverage milestones, Tonix is expanding its sales force by 50 new representatives, aiming for a total of 150 by mid-third quarter 2026.

Tonix Pharmaceuticals announced a major managed Medicare agreement for TONMYA, effective January 1, 2027, adding approximately 9 million Medicare lives. This expands TONMYA's total pharmacy coverage to about 145 million covered lives, representing 46% of all covered lives in the U.S., building on previous commercial and Medicaid agreements. Following these coverage milestones, Tonix is expanding its sales force by 50 new representatives by mid-Q3 2026, bringing the total to 150, to capitalize on the increased patient access.

Tonix Pharmaceuticals announced the enrollment of the first participant in HORIZON, a potentially pivotal Phase 2 study for TNX-102 SL 5.6 mg. This study evaluates the drug as a first-line monotherapy for adults with major depressive disorder (MDD). The randomized, double-blind, placebo-controlled trial expects to enroll approximately 360 patients, with the primary endpoint being the change in MADRS total score at Week 6. TNX-102 SL is already FDA-approved for fibromyalgia under the brand name TONMYA®.

Tonix Pharmaceuticals Holding Corp. announced a new agreement with a group purchasing organization (GPO) that expands commercial coverage for its drug TONMYA®. This deal, effective June 1, 2026, adds approximately 17 million U.S. commercial lives, bringing the total commercial coverage to about 52 million lives. TONMYA is also available to approximately 75 million Medicaid beneficiaries, with ongoing discussions for Medicare coverage.

Tonix Pharmaceuticals announced an agreement with a second leading group purchasing organization (GPO), effective June 1, 2026, expanding commercial coverage for TONMYA to an additional 17 million U.S. lives. This new agreement brings the total commercial coverage for TONMYA to approximately 52 million lives, representing about 29% of the total U.S. commercial lives. TONMYA, the first new FDA-approved fibromyalgia medicine in over 15 years, is also available in most states under Medicaid, covering approximately 75 million lives.

Tonix Pharmaceuticals presented real-world claims analysis data on opioid use in U.S. adults with fibromyalgia at the 2026 ASCP Annual Meeting. The analysis of over 261,000 patients in 2023-2024 demonstrated a substantial and persistent health burden associated with prescribed opioid use. This data supports the urgent need for non-opioid, FDA-approved treatments like Tonix's TONMYA, which was commercially launched in November 2025 as the first new fibromyalgia drug in over 15 years. The study highlighted high rates of opioid prescription across various insurance types and age groups, along with significant concomitant opioid and benzodiazepine use.

Tonix Pharmaceuticals announced the publication of positive Phase 1 clinical data for TNX-1500, an Fc-modified anti-CD154 monoclonal antibody, in the Journal of Clinical Immunology. The study in 26 healthy adults showed TNX-1500 was well-tolerated and effectively blocked T cell-dependent antibody responses, supporting its development for organ transplant rejection and autoimmune diseases. A Phase 2 investigator-initiated study for kidney transplant rejection is expected to begin in the second half of 2026, pending FDA IND clearance.

Tonix Pharmaceuticals announced the publication of positive Phase 1 data for TNX-1500, an investigational anti-CD40L monoclonal antibody, in the Journal of Clinical Immunology. The study in healthy adults showed TNX-1500 was generally well tolerated with a favorable safety profile and effectively suppressed T cell-dependent antibody responses, supporting monthly intravenous dosing. A Phase 2 investigator-initiated study for kidney transplant rejection prevention is expected to begin in the second half of 2026 at Massachusetts General Hospital, pending FDA IND clearance.

Tonix Pharmaceuticals presented data from a real-world claims analysis characterizing U.S. adults with fibromyalgia at ISPOR 2026. The study, covering over 261,000 patients in 2023-2024, highlighted a high comorbidity burden, multimodal treatment approaches, and extensive healthcare resource utilization (HCRU) among fibromyalgia patients. These findings underscore the significant unmet need that Tonix aims to address with TONMYA, which commercially launched in November 2025 as the first new fibromyalgia drug approved in over 15 years.

Tonix Pharmaceuticals presented positive pharmacokinetic data from its Phase 1 trial for TNX-4800, a product candidate for Lyme disease, at the Global Lyme Alliance. The data supports the feasibility of a two-dose 350 mg regimen maintaining protective serum levels for six months, which is the proposed primary endpoint for the upcoming Phase 2 study. The company plans to initiate an adaptive Phase 2 field study for TNX-4800 in the first half of 2027, pending agreement by the U.S. Food and Drug Administration.