Tonix Pharmaceuticals

TNXP

Market cap $199M

TONMYA (cyclobenzaprine HCl sublingual tablets) for long-term daily dosing at bedtime, is the first new FDA-approved treatment for fibromyalgia in adults in more than 15 years

TNX-4800 is a long-acting anti-Borrelia burgdorferi OspA human monoclonal antibody in development as a single-dose Lyme prophylactic   Phase 1 study of TNX-4800 demonstrated safety, tolerability, and pharmacokinetics supportive of approximately four months protection   Company expects to initiate a randomized, double-blind, placebo-controlled, adaptive Phase 2 field study in the first half of 2027, pending FDA clearance   BERKELEY HEIGHTS, N.J., March 31, 2026 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully integrated, commercial biotechnology company, announced Phase 1 data of TNX-4800 (formerly known as mAb 2217LS)1,2 was presented by Mark S.

Intranasal oxytocin blocks the release of calcitonin gene-related peptide (CGRP) in animal models and is the core technology of TNX-1900 for craniofacial pain conditions, including migraine and trigeminal neuralgia

Monday, March 30: Phase 1 data on TNX-4800 (long-acting anti-Borrelia OspA human monoclonal antibody) for the seasonal prevention of Lyme disease

BERKELEY HEIGHTS, N.J., March 18, 2026 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully integrated, commercial biotechnology company, announced today that Seth Lederman, MD, Chief Executive Officer, will deliver a company presentation at BIO-Europe Spring 2026, being held March 23-25, 2026, in Lisbon, Portugal.

BERKELEY HEIGHTS, N.J., March 17, 2026 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully integrated, commercial biotechnology company, today announced an oral presentation and two poster presentations on its preclinical immuno-oncology portfolio at the American Association for Cancer Research (AACR) Annual Meeting 2026, being held April 17–22, 2026, in San Diego, California.

Tonix Pharmaceuticals reported Q4 GAAP EPS of -$3.98 (miss), but revenue surged 109% YoY to $5.39M, beating consensus by $2.42M. Early Tonmya launch metrics show promising initial uptake, with 4,200 prescriptions and 1,500+ prescribers, but revenue conversion remains uncertain due to pending insurance coverage. Operating expenses hit $138.8M in FY25, driving a net loss of $124M, though cash reserves doubled to $207.6M, supporting operations into Q1 2027.

Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) shares are up during Friday's premarket session as the company recently reported its fourth-quarter and full-year financial results, highlighting significant developments in its product pipeline.

TONMYA™ (cyclobenzaprine HCl sublingual tablets) launched November 17, 2025, for the treatment of fibromyalgia; through February 27, 2026, more than 1,500 healthcare providers have prescribed TONMYA to patients, approximately 2,500 patients have initiated treatment with TONMYA, and cumulative prescriptions totaled approximately 4,200

Company launched TONMYA, approved by the FDA as a treatment for fibromyalgia, in November 2025 In post hoc analysis of the pivotal RESILIENT study, TONMYA produced rapid pain relief as early as Day 2 of treatment, with durable pain reduction and significant improvements in all key secondary endpoints as compared to placebo In pooled post hoc analysis of the pivotal RELIEF and RELISIENT studies, TONMYA showed favorable benefit-risk profile using number needed to treat, number needed to harm, and likelihood to be helped or harmed BERKELEY HEIGHTS, N.J., March 10, 2026 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully integrated, commercial biotechnology company, announced two oral presentations on TONMYATM, which was investigated as TNX-102 SL (cyclobenzaprine HCl sublingual tablets) at the 8th International Congress on Controversies in Fibromyalgia held on March 9-10, 2026, in Krakow, Poland.