Core Insights - Tonix Pharmaceuticals is initiating an open-label Phase 2 study of TNX-1500 to evaluate its safety and activity in kidney transplant recipients, with the study expected to start in the first half of 2026 [1][2] - TNX-1500 is designed to reduce the exposure to calcineurin inhibitors (CNIs) and improve transplant outcomes by selectively targeting cell-associated CD40L [1][2] - The study will assess the incidence of adverse events and secondary endpoints such as graft survival and renal function [2][3] Company Overview - Tonix Pharmaceuticals is a fully-integrated biotechnology company with a focus on developing therapies for various conditions, including central nervous system disorders, immunology, and infectious diseases [6] - The company has received FDA approval for Tonmya™, a treatment for fibromyalgia, marking the first new prescription medicine approval for this condition in over 15 years [6] - Tonix's development pipeline includes candidates for rare diseases and infectious diseases, such as TNX-2900 for Prader-Willi syndrome and TNX-801, a vaccine for mpox and smallpox [6] Clinical Development - The Phase 1 study of TNX-1500 demonstrated safety and tolerability, supporting its use in the upcoming Phase 2 trial [2][3] - The Phase 2 trial will enroll five adult kidney transplant recipients and will include a regimen of TNX-1500, tacrolimus, and corticosteroids [2] - The primary endpoint of the study is the incidence of adverse and serious adverse events at 12 months, with secondary endpoints focusing on graft survival and renal function [2][3]

Core Insights - Tonix Pharmaceuticals is conducting a pilot study named FOCUS to evaluate its investigational intranasal potentiated oxytocin products in patients with Arginine-Vasopressin Deficiency (AVP-D), a rare endocrine disorder linked to oxytocin deficiency and mental health issues [1][2] Group 1: Study Overview - The FOCUS study is a randomized, double-blind, placebo-controlled crossover trial aimed at generating preliminary data for future clinical studies on oxytocin replacement therapy in AVP-D [1][2] - The study will assess the effects of two different doses of investigational intranasal oxytocin products (6 IU, TNX-2900 and 24 IU, TNX-1900) on anxiety, depression, and socioemotional functioning in patients with AVP-D [2] Group 2: Product Information - TNX-1900 and TNX-2900 are based on Tonix's patented intranasal magnesium-potentiated oxytocin formulations, designed to enhance oxytocin receptor binding and its effects on trigeminal neurons [3] - TNX-1900 is being developed for chronic migraine prevention, while TNX-2900 targets Prader-Willi syndrome in children and adolescents [3] Group 3: Company Background - Tonix Pharmaceuticals is a fully integrated biotechnology company with a focus on central nervous system disorders, immunology, and rare diseases, among other areas [10] - The company has 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 [10]

Core Insights - Tonix Pharmaceuticals Holding Corp. announced a poster presentation for Tonmya™ (cyclobenzaprine HCl sublingual tablets) at the 2025 American College of Rheumatology Convergence, highlighting its efficacy in pain reduction and tolerability for fibromyalgia patients [1][3]. Company Overview - Tonix Pharmaceuticals is a fully-integrated biotechnology company with marketed products and a pipeline focused on central nervous system disorders, immunology, immuno-oncology, rare diseases, and infectious diseases [3]. - The company has received FDA approval for Tonmya™, marking the first new prescription medicine for fibromyalgia in over 15 years [3]. - Tonix also markets two treatments for acute migraine in adults and is developing TNX-102 SL for acute stress reaction, major depressive disorder, and other conditions [3]. Product Development - Tonmya™ is indicated for the treatment of fibromyalgia in adults and is a first-in-class, non-opioid analgesic [3][7]. - The company is developing TNX-1500, an Fc-modified humanized monoclonal antibody for organ transplant rejection and autoimmune diseases [3]. - Tonix's infectious disease portfolio includes TNX-801, a vaccine for mpox and smallpox, and TNX-4800, a monoclonal antibody for Lyme Disease prevention [3]. Clinical Presentation - The poster presentation titled "TNX-102 SL, Cyclobenzaprine HCl Sublingual Tablets, Demonstrates Pain Reduction and Favorable Tolerability in Participants With Fibromyalgia" will take place on October 27, 2025, in Chicago, Illinois [3].

Core Insights - Tonix Pharmaceuticals is advancing its immunomodulatory candidate TNX-1500, targeting CD40-ligand (CD40L) to prevent organ transplant rejection and treat autoimmune diseases, as highlighted in a recent presentation by CEO Dr. Seth Lederman at the Japan Society for Transplantation Congress [1][2]. Company Overview - Tonix Pharmaceuticals is a fully integrated biotechnology company with marketed products and a pipeline of development candidates, including TNX-1500, which is designed to inhibit CD40L [4][5]. - The company has 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 [5][6]. Product Development - TNX-1500 is an investigational humanized monoclonal antibody aimed at preventing allograft and xenograft rejection, as well as treating graft-versus-host disease (GvHD) and autoimmune diseases [4][6]. - The Phase 1 study of TNX-1500 showed favorable safety and biomarker data, supporting its continued development [2][4]. - The design of TNX-1500 aims to minimize thromboembolic risk while maintaining immunomodulatory activity, with plans for Phase 2 studies focusing on kidney transplant rejection and autoimmune indications [2][4]. Scientific Recognition - The presentation at the congress coincided with the awarding of the 2025 Nobel Prize in Physiology or Medicine to researchers who discovered T-regulatory cells, which are significant in immune response and organ transplant success [2][3]. Collaborative Efforts - The presentation included insights from academic collaborators, emphasizing the importance of CD154/CD40 blockade in transplantation, showcasing Tonix's engagement with the scientific community [3].

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]