Company Overview - Tonix Pharmaceuticals Holding Corp. is a fully-integrated commercial biopharmaceutical company with marketed products and a pipeline of development candidates [3] - The company has received FDA approval for Tonmya™, a first-in-class, non-opioid analgesic for the treatment of fibromyalgia, marking the first approval for a new prescription medicine for this condition in over 15 years [3] - Tonix also markets two treatments for acute migraine in adults and focuses on central nervous system disorders, immunology, immuno-oncology, rare diseases, and infectious diseases [3] Pipeline and Development - The company’s development portfolio includes TNX-102 SL for acute stress reaction and major depressive disorder, funded by the U.S. Department of Defense [3] - Tonix's immunology portfolio features TNX-1500, a monoclonal antibody for preventing organ transplant rejection and treating autoimmune diseases [3] - The rare disease portfolio includes TNX-2900 for Prader-Willi syndrome, while the infectious disease portfolio includes TNX-801 for mpox and smallpox, and TNX-4800 for Lyme Disease prevention [3] - TNX-4200 is a broad-spectrum antiviral agent with a contract from the U.S. DoD for up to $34 million over five years [3] Upcoming Events - Seth Lederman, M.D., CEO of Tonix Pharmaceuticals, will present at BIO-Europe 2025 on November 4, 2025, highlighting the company's strategy and pipeline [1][2]

Core Insights - Tonmya demonstrated significant reduction in fibromyalgia pain compared to placebo in the Phase 3 RESILIENT study, indicating its potential as a well-tolerated, non-opioid analgesic for adults with fibromyalgia [1][2] - The treatment was well tolerated with a discontinuation rate of 19% versus 20.8% for placebo, and minimal effects on weight or blood pressure [1][2] 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 [4] - The company received FDA approval for Tonmya on August 15, 2025, marking the first new prescription medicine approval for fibromyalgia in over 15 years [3][4] - Tonix also markets treatments for acute migraine and is developing TNX-102 SL for acute stress reaction and major depressive disorder [4] Clinical Study Details - The RESILIENT study was a 14-week randomized, double-blind, placebo-controlled trial involving 456 participants across 34 U.S. sites, meeting the 2016 American College of Rheumatology criteria for fibromyalgia [2] - Statistically significant reductions in weekly average pain scores were observed at Week 14 (p<0.0001) compared to placebo, along with improvements in sleep quality, fatigue, and other fibromyalgia symptoms [2] Treatment Profile - Tonmya's favorable tolerability profile includes minimal impact on weight and blood pressure, no adverse sexual side effects, and a low rate of adverse event-related discontinuations [2][3] - The most common adverse events were mild oral cavity reactions, which rarely led to study withdrawal [2]

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 - TNX-801 is an investigational live virus vaccine candidate aimed at providing long-lasting protection against mpox and smallpox, showing favorable safety and immunogenicity in preclinical studies [1][3][4] - The data presented at the World Vaccine Congress in Amsterdam supports the advancement of TNX-801 towards clinical development [2][3] Company Overview - Tonix Pharmaceuticals Holding Corp. is a fully-integrated biotechnology company with a focus on developing treatments for central nervous system disorders, immunology, rare diseases, and infectious diseases [5][6] - The company has received FDA approval for Tonmya, a non-opioid analgesic for fibromyalgia, marking a significant milestone in the treatment of this condition [6] Vaccine Development - TNX-801 is based on horsepox virus and has demonstrated durable immune protection for at least 14 months post-vaccination in various preclinical models [3][4] - The vaccine has shown strong neutralizing antibody responses and protection against clinical disease and mortality in non-human primate, rabbit, and murine models [3][4] - Tonix is collaborating with the Kenya Medical Research Institute to seek regulatory approval for a Phase I clinical study of TNX-801 in Kenya [4] Competitive Landscape - TNX-801 is positioned as a next-generation orthopoxvirus vaccine, potentially offering advantages over existing vaccines like Jynneos, which requires two doses and has a shorter duration of protection [4] - The investigational vaccine aims to provide a more durable T-cell immune response and can be manufactured at scale with a lower dose compared to non-replicating vaccines [4]

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 Viewpoint - Tonix Pharmaceuticals Holding Corp. is actively participating in the World Vaccine Congress–Europe 2025, showcasing its advancements in vaccine development, particularly the TNX-801 Mpox vaccine, which is aimed at enhancing vaccine effectiveness against infectious diseases [1][3]. Company Overview - Tonix Pharmaceuticals is a fully-integrated biotechnology company with marketed products and a diverse pipeline of development candidates, focusing on central nervous system disorders, immunology, rare diseases, and infectious diseases [4]. - The company has received FDA approval for Tonmya, a first-in-class non-opioid analgesic for fibromyalgia, marking the first new prescription medicine approval for this condition in over 15 years [4]. - Tonix's development portfolio includes treatments for acute migraine, acute stress reaction, major depressive disorder, organ transplant rejection, autoimmune diseases, and infectious diseases [4]. Upcoming Conference Details - Dr. Sina Bavari will present on the safety, durability, and protection of the single-dose TNX-801 Mpox vaccine on October 15, 2025 [3]. - A panel discussion moderated by Dr. Zeil Rosenberg will focus on enhancing vaccine effectiveness, using Mpox as a model, featuring experts from Tonix and other institutions [3].

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Core Insights - Tonix Pharmaceuticals has received FDA approval for Tonmya™, the first new therapy for fibromyalgia in over 15 years, with a U.S. launch expected in Q4 2025 [1][4]. Company Overview - Tonix Pharmaceuticals is a fully-integrated biotechnology company with marketed products and a pipeline of development candidates [2][4]. - The company focuses on central nervous system disorders, immunology, immuno-oncology, rare diseases, and infectious diseases [4]. Leadership Appointment - Ganesh Kamath has been appointed as Head of Market Access, effective September 29, 2025, bringing over 25 years of experience in market access, pricing, and commercial operations [2][3]. - Kamath's previous roles include Vice President at CuriaGlobal and CFO at Hutchmed International, where he established pricing governance frameworks and advanced market access strategies [3]. Product Details - Tonmya™ is indicated for the treatment of fibromyalgia in adults and is a first-in-class, non-opioid analgesic [4][7]. - The product is part of a broader portfolio that includes treatments for acute migraine and various CNS disorders [4]. Development Pipeline - Tonix's development pipeline includes TNX-102 SL for acute stress reaction, TNX-1500 for organ transplant rejection, TNX-2900 for Prader-Willi syndrome, and TNX-801 for mpox and smallpox [4]. - The company has a contract with the U.S. Department of Defense for TNX-4200, a broad-spectrum antiviral agent, valued at up to $34 million over five years [4].

Core Insights - Tonix Pharmaceuticals is advancing its TNX-2900 program into a Phase 2 clinical trial for the treatment of Prader-Willi Syndrome (PWS), a rare genetic disorder with significant unmet medical needs [1][2] - TNX-2900 is a magnesium-potentiated intranasal oxytocin formulation aimed at improving receptor binding and reducing dose-related inconsistencies [1][4] - The FDA has granted TNX-2900 Orphan Drug and Rare Pediatric Disease designations, which may provide a Priority Review Voucher upon approval [1][2] Group 1: Clinical Trial Details - The Phase 2 trial will be randomized, double-blind, placebo-controlled, and will include participants aged 8 to 17.5 years [2] - Participants will receive 12 weeks of treatment with TNX-2900 at one of three dose levels or placebo in a 1:1:1:1 ratio [2] - The primary efficacy endpoint is the change from baseline in the Hyperphagia Questionnaire for Clinical Trials (HQ-CT) [2] Group 2: Prader-Willi Syndrome Overview - PWS affects approximately 1 in 10,000 to 1 in 30,000 births and is characterized by severe hyperphagia, behavioral challenges, and obesity [3][5] - The average life expectancy for individuals with PWS is less than 30 years, highlighting the urgent need for effective treatments [2][6] - Current interventions for PWS are often inadequate and difficult to sustain [3] Group 3: Mechanism of Action - Research indicates that PWS is associated with a functional deficiency of oxytocin, which regulates feeding behaviors [4][6] - TNX-2900 aims to enhance oxytocin receptor binding and signaling while minimizing off-target effects related to vasopressin [4][7] - Previous studies have shown that intranasal oxytocin therapy can improve behaviors associated with PWS [6] Group 4: Company Background - Tonix Pharmaceuticals is a fully-integrated biotechnology company with a focus on central nervous system disorders, immunology, and infectious diseases [8] - The company has recently received FDA approval for Tonmya, a non-opioid analgesic for fibromyalgia, marking a significant milestone in its product development [8] - Tonix is also developing other candidates targeting various conditions, including TNX-801 for mpox and smallpox [8]