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 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.
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.