Welcome to our dedicated page for Tonix Pharmaceut news (Ticker: TNXP), a resource for investors and traders seeking the latest updates and insights on Tonix Pharmaceut stock.
Tonix Pharmaceuticals Holding Corp. develops and commercializes biotechnology products for central nervous system disorders, immunology, infectious diseases and rare diseases. Company news centers on TONMYA, an FDA-approved cyclobenzaprine HCl sublingual tablet for fibromyalgia in adults, along with marketed acute migraine products Zembrace SymTouch and Tosymra.
Recurring updates also cover Tonix’s development pipeline, including TNX-4800, a long-acting anti-Borrelia OspA human monoclonal antibody for Lyme disease prophylaxis; TNX-1900 intranasal potentiated oxytocin for craniofacial pain conditions; TNX-1700 and TNX-4700 immuno-oncology programs; TNX-801 vaccine research; and TNX-1500 for prevention of kidney transplant rejection. Other company developments include scientific presentations, clinical and preclinical data, commercial access arrangements, operating results, capital-structure disclosures and governance matters.
Tonix Pharmaceuticals (Nasdaq: TNXP) reported publication in the peer‑reviewed Journal of Virology of new preclinical data on mpox. Tonix scientists showed that the 2022 outbreak clade IIb mpox virus is approximately 100 to 100,000‑fold less virulent than the historic 2003 clade IIa in multiple mouse models.
The study expands the CAST/EiJ mouse system to older animals and introduces three novel C57BL/6 models lacking interferon‑α, interferon‑γ, or both receptors. According to Tonix, these models will support investigation of mpox pathogenesis and assessment of medical countermeasures, including its investigational vaccine candidate TNX‑801.
Tonix Pharmaceuticals (Nasdaq: TNXP) announced a major managed Medicare agreement for TONMYA, adding approximately 9 million Medicare lives, or 16% of about 55 million U.S. Medicare lives. The agreement is effective January 1, 2027.
Combined with two previously announced commercial payer agreements effective in the second quarter of 2026 and Medicaid availability in most states (about 73 million lives), pharmacy coverage for TONMYA is expected to reach approximately 145 million covered lives, or 46% of an estimated 314 million covered lives. Tonix plans to expand its sales force by 50 representatives to about 150 by mid-third quarter 2026 to support TONMYA’s launch.
Tonix Pharmaceuticals (Nasdaq: TNXP) enrolled the first patient in HORIZON, a potentially pivotal Phase 2, randomized, double-blind, placebo-controlled study of TNX-102 SL 5.6 mg as first-line monotherapy for adults with major depressive disorder.
The 6-week U.S. trial will enroll about 360 patients at ~30 sites, measuring change in MADRS score at Week 6. TNX-102 SL, marketed as TONMYA, was FDA-approved in August 2025 for fibromyalgia in adults.
Tonix Pharmaceuticals (Nasdaq: TNXP) will attend BTIG Infectious Disease Day 2026, holding virtual 1x1 investor meetings on June 16, 2026. President and CEO Seth Lederman, M.D., will participate. Tonix develops CNS and immunology treatments and advances several Phase 2 ready programs.
Tonix Pharmaceuticals (Nasdaq: TNXP) signed a second commercial payer agreement for TONMYA, effective June 1, 2026, via a leading GPO. The deal adds coverage for ~17 million U.S. commercial lives, bringing total commercial coverage to ~52 million lives, about 29% of U.S. commercial lives.
TONMYA, a cyclobenzaprine HCl sublingual tablet and first new fibromyalgia medicine for adults in over 15 years approved by the FDA, also has Medicaid coverage in most states representing ~75 million lives. A TONMYA Together Support Program offers savings for eligible commercially insured patients.
Tonix Pharmaceuticals (Nasdaq: TNXP) presented a retrospective U.S. real-world claims analysis of opioid and benzodiazepine use in adults with fibromyalgia at the 2026 ASCP Meeting.
The Year 3 cohort (2023-2024) included 261,776 adults and showed substantial, persistent health burden linked to prescribed opioid use. Tonix also highlighted its FDA-approved, non-opioid fibromyalgia medicine TONMYA, commercially launched in November 2025.
Tonix Pharmaceuticals (Nasdaq: TNXP) reported Phase 1 results for TNX-1500, an Fc-modified anti-CD40L monoclonal antibody in development to prevent organ transplant rejection and treat autoimmune disease. Tonix describes TNX-1500 as a third-generation, Phase 2–ready candidate.
In 26 healthy adults, single intravenous doses (3–30 mg/kg) were generally well tolerated with no serious adverse events or discontinuations, dose-proportional exposure, and half-lives around 34–38 days. TNX-1500 suppressed T cell–dependent antibody responses to KLH and reduced soluble CD40L for 120 days. A Phase 2 investigator-initiated kidney transplant study at Massachusetts General Hospital is expected to begin in 2H 2026, pending FDA IND clearance.
Tonix Pharmaceuticals (Nasdaq: TNXP) presented a U.S. real-world claims analysis of adults with fibromyalgia at the ISPOR 2026 annual meeting. The study used three years of Symphony Health closed claims data, focusing on Year 3 (April 2023–March 2024).
Key findings included 261,776 adult patients (median age 53; 92.1% female) and a high comorbidity burden, with 93.2% having at least one fibromyalgia-related comorbidity. Among insured patients, inpatient services averaged $29,896 per patient annually, followed by pharmacy at $9,453 and outpatient at $6,196, indicating substantial healthcare resource use. Antidepressants, NSAIDs, anticonvulsants, gastric acid reducers, muscle relaxants, and opioids were frequently used, reflecting multimodal treatment. Tonix noted the recent U.S. commercial launch of TONMYA in November 2025 as a non-opioid bedtime analgesic for fibromyalgia.
Tonix Pharmaceuticals (Nasdaq: TNXP) will present a poster at ISPOR 2026 in Philadelphia, May 17-20, 2026. The retrospective cohort study uses U.S. claims data from April 2021-April 2024 to characterize adults with fibromyalgia.
The research is linked to TONMYA, approved by the U.S. FDA on August 15, 2025 and launched November 17, 2025. Poster RWD167 will be presented May 20, 2026, 9:00-11:30 a.m. ET, and the poster will later be available on Tonix’s website.
Tonix Pharmaceuticals (Nasdaq: TNXP) will participate in two investor conferences in May 2026. CEO Seth Lederman will join fireside chats at the RBC Capital Markets Global Healthcare Conference in New York on May 19, 2026, and A.G.P.’s Annual Virtual Healthcare Conference on May 20, 2026.
Live webcasts and replays will be available on Tonix’s investor relations website.