Tonix Pharmaceuticals Holding Corp

Tonix Pharmaceuticals reported second quarter 2026 net product revenue of approximately $13.5 million, driven by $11 million in net sales of its fibromyalgia drug TONMYA, a 197% quarter-over-quarter increase. The company also announced it is expanding its sales force by 50 representatives to roughly 150 by September, and that TONMYA now covers approximately 136 million lives, or 43% of covered lives in the United States. Tonix advanced its pipeline, randomizing the first patient in a Phase II study of TNX-102 SL for major depressive disorder and receiving positive FDA meeting minutes for a planned adaptive Phase II study of TNX-4800 for Lyme disease prevention, with enrollment expected in the first quarter of 2027. The company ended the quarter with $176.2 million in cash and cash equivalents, and expects its resources to fund operations into early second quarter of 2027.

Tonix Pharmaceuticals has signed a new managed Medicare payer agreement for its fibromyalgia treatment TONMYA, extending potential coverage to around 9 million additional Medicare beneficiaries effective January 1, 2027. This agreement represents approximately 16% of the estimated 55 million Medicare-covered lives in the United States. Combined with two previously announced commercial payer agreements effective in the second quarter of 2026 and Medicaid coverage for roughly 73 million people, pharmacy access to TONMYA is projected to reach around 145 million covered lives, or about 46% of the 314 million insured lives in the U.S., from January 1, 2027. To support the broader rollout, Tonix plans to add 50 sales representatives by mid-third quarter 2026, bringing its total sales force to approximately 150. TONMYA received FDA approval on August 15, 2025, as the first newly approved prescription treatment for fibromyalgia in more than 15 years, with U.S. market exclusivity expected through 2034.

Tonix Pharmaceuticals has enrolled the first patient in its potentially pivotal Phase 2 HORIZON study evaluating TNX-102 SL as a first-line monotherapy for adults with major depressive disorder. The randomized, double-blind, placebo-controlled trial is expected to enroll approximately 360 patients across about 30 U.S. sites, with the primary endpoint being the change from baseline in the Montgomery-Åsberg Depression Rating Scale total score at Week 6. TNX-102 SL, a sublingual formulation of cyclobenzaprine hydrochloride, was approved by the FDA in August 2025 and launched commercially as TONMYA for fibromyalgia. The company is now exploring its potential in MDD, targeting disturbed sleep quality through antagonism at four neuronal receptors.