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) 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.
Tonix Pharmaceuticals (Nasdaq:TNXP) reported first quarter 2026 net product revenue of approximately $6.9 million, up from $2.4 million a year earlier, driven by the first full quarter of TONMYA sales of about $3.7 million.
Approximately 2,145 prescribers wrote TONMYA, 3,588 patients initiated therapy, and ~5,400 prescriptions were filled. Cash and equivalents were about $185.5 million, which Tonix believes, along with recent equity proceeds, will fund operations into early second quarter 2027. Key pipeline updates include Phase 2 plans for TNX-4800 in Lyme disease and TNX-102 SL in major depressive disorder.
Tonix Pharmaceuticals (Nasdaq: TNXP) announced an agreement effective May 1, 2026, with a leading GPO to provide commercial payer coverage for TONMYA to approximately 35 million U.S. commercial lives (about 20% of ~177 million).
TONMYA, launched commercially in November 2025, is the first FDA-approved fibromyalgia treatment in over 15 years and is indicated as a daily bedtime medicine for long-term use. TONMYA also has Medicaid coverage in 38 states covering ~55 million lives (73% of ~75 million Medicaid lives).
Tonix Pharmaceuticals (Nasdaq: TNXP) presented Phase 1 data and outlined plans for an adaptive, randomized, double-blind, placebo-controlled Phase 2 field study of TNX-4800 for prevention of Lyme disease.
Pending FDA agreement, Tonix expects to initiate the two-dose subcutaneous study in the first half of 2027 (Spring dose, two-month booster) with a primary endpoint measuring prevention of confirmed Lyme disease from Day 3 through Month 6. The company says Phase 1 PK supports fixed doses comparable to 5 mg/kg and that TNX-4800 may provide protection within two days. A Type C meeting with FDA is scheduled early Q3 2026; GMP investigational product is expected early 2027.
Tonix Pharmaceuticals (Nasdaq: TNXP) presented preclinical immuno-oncology data at AACR 2026 on TNX-1700 (TFF2-albumin fusion) and TNX-4700 (anti-BTLA mAb). TNX-1700 reversed aging-associated gastric inflammation, attenuated tumor progression in aged models, and showed dose-independent, linear pharmacokinetics with extended TFF2 half-life. TNX-4700 demonstrated potent, high-affinity binding and in vitro functional antagonism of BTLA.
All treated animals survived without >10% weight loss. Copies of the two posters are available on the company website.
Tonix Pharmaceuticals (Nasdaq: TNXP) reported publication of steady-state pharmacokinetics for TONMYA (TNX-102 SL) after 20 days of daily dosing in Clinical Pharmacology in Drug Development on April 15, 2026.
The single-center study (N=60) compared nightly sublingual cyclobenzaprine HCl 5.6 mg to oral ER 30 mg over 20 days, showing earlier tmax, higher dose-normalized bioavailability for the sublingual tablet, lower absolute plasma exposures, comparable metabolite profiles, and generally mild-to-moderate adverse events.