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) announced that CEO Seth Lederman, MD, will present at BIO-Europe Spring 2026 in Lisbon on March 24, 2026, from 1:30-1:45 p.m. WET in the Presentation Theatre A. The presentation will cover the company’s CNS and immunology programs and marketed products.
Tonix Pharmaceuticals (Nasdaq: TNXP) will present one oral and two poster presentations on its preclinical immuno-oncology portfolio at the AACR Annual Meeting 2026, April 17–22 in San Diego. Presentations cover TFF2-driven gastric tumor biology, anti-BTLA antibodies, and TNX-1700 pharmacokinetics in animal models.
Oral presentation is April 21, 2026; poster sessions are April 21–22, 2026. Copies of the presentations will be available under the Scientific Presentations tab on the company website.
Tonix Pharmaceuticals (Nasdaq: TNXP) reported 2025 results and operational highlights, including the November 17, 2025 launch of TONMYA for fibromyalgia and commercial metrics through February 27, 2026: ~1,500 prescribers, ~2,500 patients initiated, and ~4,200 cumulative prescriptions.
The company held $207.6M in cash at December 31, 2025, completed a $20.0M registered direct offering, and raised $8.6M via ATM; full-year net product revenue was $13.1M.
Tonix Pharmaceuticals (Nasdaq: TNXP) reported post hoc Phase 3 analyses of TONMYA (cyclobenzaprine HCl sublingual tablets) presented March 9–10, 2026. Key findings include rapid pain relief as early as Day 2, Week 14 primary endpoint superiority (LS mean diff -0.65, p<0.001), and favorable pooled benefit-risk metrics (NNT 7; NNH 26; LHH 3.7).
The company noted TONMYA was generally well tolerated; oral cavity reactions were the most common adverse events.
Tonix Pharmaceuticals (Nasdaq: TNXP) presented Phase 3 data for TONMYA (cyclobenzaprine HCl sublingual tablets) at the 2026 AAPM PainConnect Annual Meeting. The 14-week RESILIENT trial (n=457) showed statistically significant mean daily pain reduction and higher 30% responder rates versus placebo. TONMYA received FDA approval in August 2025 and launched commercially in November 2025. The drug was generally well tolerated; most adverse events were mild, self-limited oral cavity reactions that rarely caused withdrawal.
Tonix Pharmaceuticals (NASDAQ: TNXP) announced publication of Phase 1 pharmacokinetic studies of TONMYA (TNX-102 SL), a sublingual cyclobenzaprine formulation FDA-approved Aug 15, 2025 and commercially launched Nov 2025. Two single-dose studies (n=24 and n=16) showed rapid transmucosal absorption, 154% relative bioavailability versus oral IR, ~3-minute absorption lag versus ~37 minutes, a 783% higher dose-normalized AUC in the first hour, dose proportionality, no food effect, and a norcyclobenzaprine elimination half-life of ~60 hours. Single doses were generally well tolerated; common AEs included oral hypoesthesia and abnormal taste.
Tonix Pharmaceuticals (Nasdaq: TNXP) will present a poster on Tonmya™ (cyclobenzaprine HCl sublingual tablets) at the 2026 American Academy of Pain Medicine PainConnect Annual Meeting, March 5–8, 2026 in Salt Lake City.
Poster #50, titled "Treatment with TNX-102 SL Produces Clinically Meaningful Improvements in Patient-Centered Outcomes in Fibromyalgia," will be presented March 6, 2026 at 4:55 PM ET by Errol Gould, PhD. A copy of the presentation will be available on the company presentations webpage.
Tonix Pharmaceuticals (Nasdaq: TNXP) announced approval to transfer its listing from the Nasdaq Capital Market to the Nasdaq Global Select Market, effective at market open on March 3, 2026, under the existing ticker TNXP.
The company says the uplisting reflects compliance with higher financial and governance standards and may enhance visibility, liquidity and institutional access. Tonix is a commercial-stage biotech with recently approved TONMYA™ for fibromyalgia and marketed acute migraine products, plus multiple investigational CNS and immunology programs.
Tonix Pharmaceuticals (Nasdaq: TNXP) said management will participate in two investor conferences in March 2026: a company presentation at TD Cowen on March 4, 2026 and 1x1 meetings at Barclays from March 10–12, 2026.
A live webcast of the March 4 presentation will be available on the company's Investor Events page, with a replay accessible for 90 days. The company highlighted its recently approved flagship product TONMYA and a CNS and immunology pipeline including TNX-2900, TNX-4800, and TNX-1500.
Tonix Pharmaceuticals (Nasdaq: TNXP) presented positive Phase 3 RESILIENT data for TONMYA (sublingual cyclobenzaprine HCl) at the 2026 Non-Opioid Pain Therapeutics Summit on January 29, 2026.
In a 14-week, 456-participant randomized double-blind trial, TONMYA produced a statistically significant reduction in weekly average pain at Week 14 (p<0.0001; effect size 0.38) and significant improvements in sleep, fatigue, and Fibromyalgia Impact Questionnaire domains. TONMYA was approved by the FDA on August 15, 2025, and was generally well tolerated with low weight and blood pressure effects.