Tonix Pharmaceuticals

TNXP

Market cap $187M

Real-world analysis of three years of closed claims data from Symphony Health, focused on the third year of the study (2023-2024), comprised of more than 261,000 U.S. adults with fibromyalgia

Phase 1 data support TNX-1500 as a potentially first-in-class, best-in-class, third-generation anti-CD40L monoclonal antibody for the prevention of kidney transplant rejection Phase 2 investigator-initiated study in adult kidney transplant at Massachusetts General Hospital (MGH) expected to initiate in the 2 nd half of 2026 pending U.S. Food and Drug Administration (FDA) clearance of MGH's Investigational New Drug (IND) application BERKELEY HEIGHTS, N.J., May 27, 2026 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully integrated, commercial-stage biotechnology company, today announced the publication of a paper, “First-in-Human, Phase 1, Randomized, Double-Blind, Placebo-Controlled Study of TNX-1500, an Fc-Modified anti-CD154 Monoclonal Antibody, Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single-Ascending Doses in Healthy Adults,” in the peer-reviewed Journal of Clinical Immunology.

Real-world analysis of three years of closed claims data from Symphony Health focused on the third year of the study (2023-2024), comprised of more than 261,000 U.S. adults with fibromyalgia

BERKELEY HEIGHTS, N.J., May 14, 2026 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) ("Tonix" or the "Company"), a fully integrated, commercial biotechnology company, today announced a poster presentation at ISPOR 2026, the Professional Society for Health Economics and Outcomes Research's annual meeting, being held May 17-20, 2026, in Philadelphia, Pennsylvania. The retrospective cohort study utilized U.S. claims data from April 2021-April 2024 to analyze adults with fibromyalgia. TONMYA® (cyclobenzaprine HCl sublingual tablets) was approved by the U.S. FDA on August 15, 2025, and commercially launched in the U.S. on November 17, 2025.

BERKELEY HEIGHTS, N.J., May 12, 2026 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) ("Tonix" or the "Company"), a fully integrated, commercial biotechnology company, today announced that the management team will participate in two upcoming investor conferences in May 2026.

In the first full quarter since launch, 2,145 healthcare providers prescribed TONMYA®, 3,588 patients initiated treatment, and ~5,400 prescriptions were filled

Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) shares are trading higher Wednesday after the company announced commercial payer coverage for its fibromyalgia treatment TONMYA.

Agreement with leading group purchasing organization (GPO) provides access to approximately 35 million U.S. commercial lives (20% of ~177 million commercial lives in the U.S.) TONMYA (cyclobenzaprine HCl sublingual tablets), the first FDA-approved treatment for fibromyalgia in adults in more than 15 years, commercially launched in November 2025 TONMYA is a first-in-class non-opioid analgesic indicated for the treatment of fibromyalgia in adults as a daily bedtime medicine for long-term use BERKELEY HEIGHTS, N.J., May 06, 2026 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a fully integrated, commercial biotechnology company, today announced an agreement effective May 1, 2026, with a leading group purchasing organization (GPO) that provides coverage to approximately 35 million U.S. commercial lives, representing approximately 20% of the roughly 177 million commercial lives in the U.S., with standard utilization management criteria, for TONMYA® (cyclobenzaprine HCl sublingual tablets).

Company on track to initiate a randomized, double-blind, placebo-controlled, adaptive Phase 2 field study in the first half of 2027, pending FDA agreement Phase 2 field study expected to test a two-dose regimen of TNX-4800 subcutaneous with an initial Spring dose followed by a Summer booster two months later; the primary endpoint is Lyme disease prevention for six months TNX-4800 is expected to provide protection against Lyme disease within two days of the first dose for the peak of the U.S. Lyme season BERKELEY HEIGHTS, N.J., April 29, 2026 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully integrated, commercial biotechnology company, announced presentation of Phase 1 data and plans for an adaptive Phase 2 field study of TNX-4800 (formerly known as mAb 2217LS)1,2 for the prevention of Lyme disease in the U.S., at the 4th Annual Ticks and Tickborne Diseases Symposium.

TNX-1700 (TFF2-albumin fusion protein) reversed aging-associated gastric inflammation and significantly attenuated tumor progression in aged gastric microenvironment in preclinical models TNX-1700 exhibited dose-independent, linear pharmacokinetics in animals TNX-4700 (human anti-BTLA monoclonal antibody) demonstrated potent, high-affinity binding and functional antagonism BERKELEY HEIGHTS, N.J., April 23, 2026 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully integrated, commercial biotechnology company, today announced an oral presentation and two poster presentations on its preclinical immuno-oncology portfolio at the American Association for Cancer Research (AACR) Annual Meeting 2026, held April 17-22, 2026, in San Diego, California.