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. (Nasdaq: TNXP) generates a steady flow of news as a fully integrated, commercial-stage biotechnology company with both marketed products and a broad development pipeline. News coverage for Tonix often centers on its FDA-approved fibromyalgia treatment TONMYA, its acute migraine products Zembrace SymTouch and Tosymra, and updates on clinical and regulatory milestones across central nervous system, immunology, rare disease and infectious disease programs.
Investors following TNXP news can expect announcements on commercial launches, market access decisions, and distribution arrangements for TONMYA, as well as prescription trends and formulary placements for its migraine therapies. The company also regularly reports progress on TNX-102 SL in indications such as acute stress-related conditions and major depressive disorder, including IND clearances and the design of potentially pivotal Phase 2 studies.
Tonix’s immunology and infectious disease work contributes additional news items, including collaborations with academic centers like Massachusetts General Hospital for TNX-1500 in kidney transplantation, and development plans for TNX-4800, a monoclonal antibody designed for seasonal prevention of Lyme disease. Licensing transactions, such as the acquisition of TNX-4900 for chronic neuropathic pain from Rutgers University, and government-supported projects like the DTRA-backed antiviral TNX-4200, are also common themes in company press releases.
This TNXP news page aggregates company-issued updates and related coverage so readers can quickly review developments in Tonix’s commercial operations, clinical pipeline, financing activities, and strategic collaborations. For investors and observers tracking biotech catalysts, revisiting this page provides a concise way to monitor how Tonix’s programs and capital markets actions evolve over time.
Tonix Pharmaceuticals (Nasdaq: TNXP) reported Phase 1 results for TNX-4800, a single-dose anti-Borrelia burgdorferi OspA monoclonal antibody showing safety, tolerability, and pharmacokinetics consistent with ~four months protection.
The company plans a randomized, double-blind, placebo-controlled adaptive Phase 2 field study (fixed 350 mg dose) expected to start in H1 2027, pending FDA clearance.
Tonix Pharmaceuticals (Nasdaq: TNXP) announced dosing of the first participant in a Phase 1 investigator-initiated study of TNX-1900 (intranasal potentiated oxytocin) to assess trigeminal neurovascular reactivity as a model for migraine and craniofacial pain on March 26, 2026.
The study, led by Dr. Antoinette Maassen van den Brink in collaboration with Tonix, will measure forehead dermal blood flow responses to capsaicin and electrical stimulation using Laser Speckle Contrast Imaging (LSCI). Preclinical data show intranasal oxytocin can block CGRP release in animal models; TNX-1900 targets a pathway distinct from CGRP inhibitors.
Tonix Pharmaceuticals (Nasdaq: TNXP) announced presentations at World Vaccine Congress Washington 2026 in Washington, D.C., March 30–April 2, 2026. Highlights include a March 30 oral presentation of Phase 1 data on TNX-4800 for seasonal Lyme prevention and April 1 talks on TNX-801 and pox-based antigen delivery.
Speakers include Mark S. Klempner, MD, Farooq Nasar, PhD, and Christopher Cooper, PhD, with session times and rooms listed for each presentation.
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.