Tonix Pharmaceuticals

TNXP

Market cap $163M

TNX-801 is a live virus vaccine investigational candidate, designed to provide durable protection against mpox and smallpox

CHATHAM, N.J., Oct. 14, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully integrated biotechnology company with marketed products and a pipeline of development candidates, today announced that Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals, delivered a presentation titled “The History and Promise of anti-CD154 Monoclonal Antibody Immunomodulation for Transplantation,” at the 61st Annual Congress of the Japan Society for Transplantation, which took place October 9–11, 2025, in Nagoya, Japan. The CD40-ligand (CD40L) is also known as CD154. A copy of the Company's presentation is available under the Presentations tab of the Tonix website at https://ir.tonixpharma.com/presentations.

CHATHAM, N.J., Oct. 09, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully-integrated biotechnology company with marketed products and a pipeline of development candidates, today announced that Dr. Sina Bavari, Ph.D., Executive Vice President, Infectious Disease Research, will present and Dr. Bavari and Dr. Zeil Rosenberg, M.D., Executive Vice President, Medical will participate in a panel discussion at the World Vaccine Congress–Europe 2025, taking place October 14–16, 2025, in Amsterdam, the Netherlands. Details on both sessions are provided below.

Tonix Pharmaceuticals (NASDAQ:TNXP) announced the appointment of Ganesh Kamath as its head of market access, effective September 29, 2025.   The biotechnology company said Kamath brings more than 25 years of market access, pricing, and commercial operations experience to Tonix.

Mr. Kamath brings more than 25 years of market access, pricing, and commercial operations experience to Tonix On August 15, 2025, the U.S. Food and Drug Administration approved Tonmya™ (cyclobenzaprine HCl sublingual tablets) for the treatment of fibromyalgia in adults, the first new fibromyalgia therapy in more than 15 years US Launch of Tonmya expected in the fourth quarter of 2025 CHATHAM, N.J., Sept. 30, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully-integrated biotechnology company with marketed products and a pipeline of development candidates, today announced the appointment of Ganesh Kamath as Head of Market Access, effective September 29, 2025.

Phase 2 randomized, double-blind, placebo-controlled trial planned to evaluate TNX-2900 in children and adolescents (ages 8 to 17.5 years) with Prader-Willi Syndrome under a cleared IND

Tonix anticipates filing the IND application in the fourth quarter of 2025 TNX-102 SL is a potential first-in-class treatment for targeting the disturbed sleep associated with depression TNX-102 SL is FDA-approved for the treatment of fibromyalgia CHATHAM, N.J., Sept. 18, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a fully-integrated biotechnology company with marketed products and a pipeline of development candidates, today announced the successful completion of a Type B Pre-Investigational New Drug (Pre-IND) meeting with the U.S. Food and Drug Administration (FDA) regarding the development of TNX-102 SL (sublingual cyclobenzaprine HCl) for the treatment of major depressive disorder (MDD).

Positive Phase 1 study showed safety, tolerability and a linear pharmacokinetic: pharmacodynamic: efficacy relationship (1: 1: 1)

Tonmya was approved by FDA on August 15, 2025 for the treatment of fibromyalgia and is the first new FDA approved treatment for fibromyalgia in over 15 years Two pivotal Phase 3 studies demonstrated Tonmya significantly reduced fibromyalgia pain compared to placebo Tonmya showed consistent improvements across core fibromyalgia symptoms, including widespread pain, sleep disturbance and fatigue Tonmya was well tolerated, supporting its potential as a long-term treatment option for fibromyalgia Tonmya is expected to be commercially available in the fourth quarter CHATHAM, N.J., Sept. 08, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully-integrated biotechnology company with marketed products and a pipeline of development candidates, presented four posters at the PAINWEEK conference 2025, held September 2-5, 2025, in Las Vegas, Nevada entitled: “TNX-102 SL, Cyclobenzaprine HCl Sublingual Tablets, Demonstrates Pain Reduction and Favorable Tolerability in Participants With Fibromyalgia” “Sublingual Cyclobenzaprine (TNX-102 SL) for Fibromyalgia: Efficacy and Safety in Two Randomized, Placebo-Controlled Trials” “Steady-state Pharmacokinetic Properties of a Sublingual Formulation of Cyclobenzaprine (CBP) HCl (TNX-102 SL): Comparison to Simulations of Oral immediate-release CBP” “Randomized, Double-Blind, Placebo-Controlled Confirmatory Phase 3 Trial of Bedtime Sublingual Cyclobenzaprine (TNX-102 SL) in Fibromyalgia” “Fibromyalgia is a chronic and debilitating condition marked by widespread pain, poor sleep, and fatigue and cognitive dysfunction,” said Seth Lederman, M.D.

CHATHAM, N.J., Aug. 28, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully-integrated biotechnology company with marketed products and a pipeline of development candidates, today announced that Seth Lederman, M.D.