CHATHAM, N.J., Oct. 21, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully-integrated, commercial biotechnology company, announced today that a poster on Tonmya™ (cyclobenzaprine HCl sublingual tablets), which was investigated as TNX-102 SL, will be presented by Dr. Gregory Sullivan, M.D., Chief Medical Officer of Tonix Pharmaceuticals, at the 2025 American College of Rheumatology Convergence, being held October 24–29, 2025, in Chicago, Ill. A cop ...

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 Tra ...

Core Insights - Tonix Pharmaceuticals is advancing TNX-102 SL, a potential first-in-class treatment for major depressive disorder (MDD), with an IND application expected in Q4 2025 [1][3] - TNX-102 SL is already FDA-approved for fibromyalgia and is being explored for its effects on sleep quality and depressive symptoms [1][2] Company Overview - Tonix Pharmaceuticals is a fully-integrated biotechnology company with marketed products and a pipeline of development candidates [5] - The company recently received FDA approval for Tonmya™, a non-opioid analgesic for fibromyalgia, marking the first new prescription medicine approval for this condition in over 15 years [6] - Tonix's development portfolio focuses on central nervous system disorders, immunology, immuno-oncology, and infectious diseases [6] Product Development - TNX-102 SL is a patented sublingual formulation designed for rapid absorption, bypassing first-pass metabolism, and is currently approved for fibromyalgia [4] - The drug is also being developed for other indications, including acute stress reaction, PTSD, and Long COVID [4] - The FDA provided positive feedback during the Pre-IND meeting, indicating a reasonable long-term safety data collection plan [2][3] Clinical Data - In the Phase 3 RESILIENT study, TNX-102 SL showed significant improvement in depressive symptoms among fibromyalgia patients compared to placebo, with a p-value of less than 0.05 [3] - The biological relationship between depressive symptoms in fibromyalgia and MDD remains unclear [3] Intellectual Property - Tonix holds multiple patents related to TNX-102 SL, providing market exclusivity until at least 2034, with potential extensions until 2044 for method of use [4]

Company Overview - Tonix Pharmaceuticals Holding Corp. is a fully-integrated biotechnology company with marketed products and a pipeline of development candidates [3] - The company recently received FDA approval for Tonmya™, a first-in-class, non-opioid analgesic for the treatment of fibromyalgia, marking the first new prescription medicine approval for this condition in over 15 years [3] - Tonix also markets two treatments for acute migraine in adults and has a development portfolio focused on CNS disorders, immunology, immuno-oncology, and infectious diseases [3] Product Development - Tonmya™ is indicated for the treatment of fibromyalgia in adults [7] - The company is developing TNX-102 SL for acute stress reaction and acute stress disorder, funded by the U.S. Department of Defense [3] - Tonix's immunology portfolio includes TNX-1500, a monoclonal antibody for preventing allograft rejection and treating autoimmune diseases [3] - The infectious disease portfolio features TNX-801, a vaccine for mpox and smallpox, and TNX-4200, a broad-spectrum antiviral agent with a contract worth up to $34 million over five years with the U.S. DoD [3] Upcoming Events - Seth Lederman, M.D., the CEO of Tonix, will participate in a fireside chat at the 2025 Cantor Global Healthcare Conference on September 4, 2025 [1] - A webcast of the event will be available on the company's website, with a replay accessible for 90 days post-event [2]