Non-opioid analgesic shows efficacy in several animal pain models, including diabetic and chemotherapy-induced neuropathic pain Compelling safety and pharmacokinetic profiles in animals support IND-enabling studies CHATHAM, N.J., Dec. 16, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully-integrated commercial biotechnology company, today announced licensing exclusive worldwide rights to TNX-4900 (formerly known as PW507), a highly selective small ...

Group 1 - Tonix Pharmaceuticals presented promising preclinical data for its investigational mpox and smallpox vaccine candidate, TNX-801, at the World Vaccine Congress Europe 2025 [1][2] - The TNX-801 vaccine demonstrated strong immune responses, long-term protection for at least 14 months, and favorable safety across multiple animal models [2] - The company is pursuing a Phase I clinical trial in collaboration with the Kenya Medical Research Institute and is exploring microneedle patch technology for vaccine administration [2] Group 2 - Tonix Pharmaceuticals is currently unprofitable, with analysts not expecting profitability this year [2] - The company focuses on developing therapies and vaccines for central nervous system disorders, immunology, infectious diseases, and rare diseases [2] - Tonix also markets existing products for the treatment of acute migraine headaches, such as Zembrace SymTouch and Tosymra [2]

Core Insights - The RESILIENT trial data demonstrates that TNX-102 SL significantly reduces fibromyalgia pain compared to placebo, confirming previous findings from the RELIEF trial [1][2] - If approved, TNX-102 SL will be the first new drug for fibromyalgia in over 15 years, with a PDUFA target date set for August 15, 2025 [1][2] Company Overview - Tonix Pharmaceuticals Holding Corp. is a clinical-stage biopharmaceutical company focused on developing therapies for pain management and central nervous system disorders [8] - The company has submitted a New Drug Application (NDA) for TNX-102 SL based on two statistically significant Phase 3 studies [2][8] Study Details - The RESILIENT study was a randomized, double-blind, placebo-controlled trial involving 457 adults with fibromyalgia across 33 sites in the U.S. [2][7] - Participants received TNX-102 SL in two dosage phases: 2.8 mg for two weeks followed by 5.6 mg for twelve weeks, with a primary endpoint of pain reduction assessed over fourteen weeks [2][7] Efficacy Results - TNX-102 SL achieved a least-squares mean reduction of 1.8 points on the eleven-point daily pain numeric rating scale, compared to a 1.2-point reduction for placebo, indicating high statistical significance [2][7] - Statistically significant improvements were also noted across all six prespecified key secondary endpoints, including various patient-reported outcomes [2][3] Safety Profile - TNX-102 SL was generally well tolerated, with the most common adverse events being mild and transient, such as oral tingling/numbness and a bitter aftertaste [3] - No serious drug-related adverse events or deaths were reported, highlighting a favorable risk-benefit profile [3] Fibromyalgia Context - Fibromyalgia affects an estimated 6-12 million adults in the U.S., predominantly women, and is characterized by chronic pain, fatigue, and sleep disturbances [4] - Current treatment options are often met with dissatisfaction from both physicians and patients, indicating a significant unmet need in the market [4] Product Information - TNX-102 SL is a patented sublingual formulation of cyclobenzaprine hydrochloride designed for rapid absorption and reduced side effects [5][6] - The drug is also being explored for other indications, including acute stress reaction, Long COVID, and alcohol use disorder [5][8]

Core Insights - Tonix Pharmaceuticals announced that its vaccine candidate TNX-801 provides durable protection against monkeypox after a single dose [1][3] - The vaccine is well tolerated in immunocompromised animals, showing no evidence of spreading to blood or tissues even at high doses [2][3] - TNX-801 is designed to generate both humoral and cellular immunity and serves as a platform for delivering multiple protective antigens against various viral pathogens [3][4] Company Overview - Tonix Pharmaceuticals is a fully-integrated biopharmaceutical company focused on developing therapies for pain management and vaccines for public health challenges [6] - The company has a diverse development portfolio, including TNX-102 SL for fibromyalgia, which has a PDUFA goal date of August 15, 2025 [6] - Tonix's infectious disease portfolio includes TNX-801 for mpox and smallpox, and TNX-4200, a broad-spectrum antiviral agent with a contract worth up to $34 million with the U.S. Department of Defense [6]

Core Insights - TNX-102 SL is a sublingual formulation of cyclobenzaprine aimed at treating fibromyalgia, with an FDA PDUFA goal date of August 15, 2025, potentially becoming the first new non-opioid analgesic for fibromyalgia in over 15 years [1][7] - The drug has shown statistically significant improvement in reducing fibromyalgia pain in two Phase 3 studies, demonstrating durable activity over 14 weeks [2][3] - TNX-102 SL targets sleep disturbances associated with fibromyalgia and has a favorable tolerability profile, acting as a potent antagonist at four post-synaptic receptors [3][6] Company Overview - Tonix Pharmaceuticals is a biotechnology company focused on developing therapies for pain management and CNS disorders, with TNX-102 SL as a priority product candidate for fibromyalgia [7] - The company has submitted a New Drug Application (NDA) for TNX-102 SL based on positive Phase 3 study results and has received Fast Track designation from the FDA [7] - Tonix also has a diverse development portfolio, including treatments for acute stress reactions, organ transplant rejection, and infectious diseases [7] Industry Context - Fibromyalgia affects over 10 million adults in the U.S., primarily women, and is characterized by chronic pain, non-restorative sleep, and cognitive dysfunction [4] - Current treatment options are often unsatisfactory, leading many patients to rely on chronic opioids, which carry risks of addiction and overdose [2][4] - TNX-102 SL's unique formulation aims to provide a new therapeutic option that addresses both pain and sleep disturbances without the risks associated with opioids [2][6]

Core Insights - Tonix Pharmaceuticals has appointed James "Jim" Hunter to its Board of Directors, effective June 12, 2025, to strengthen its commercial strategy and governance as it prepares for the potential launch of TNX-102 SL for fibromyalgia later this year [1][2][4] Company Overview - Tonix Pharmaceuticals is a fully-integrated biotechnology company focused on transforming therapies for pain management and vaccines for public health challenges, with a development portfolio centered on central nervous system (CNS) disorders [5] - The company is advancing TNX-102 SL, a product candidate for fibromyalgia management, with a New Drug Application (NDA) submitted based on two statistically significant Phase 3 studies, and a PDUFA goal date of August 15, 2025, for marketing authorization [5] Leadership and Experience - Jim Hunter has over 40 years of experience in the biopharmaceutical industry, having held leadership roles at Validus Pharmaceuticals, Relialab, and Novartis, and was instrumental in launching Tonix Medicines and entering the migraine market [1][3] - As Executive Vice President of Commercial Operations at Tonix, Hunter managed all aspects of the company's commercial efforts, including sales, marketing, and market access initiatives [2][4] Product Development and Pipeline - Tonix's immunology development portfolio includes biologics targeting organ transplant rejection, autoimmunity, and cancer, such as TNX-1500, an Fc-modified humanized monoclonal antibody [6] - 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. Department of Defense [6] Commercial Strategy - Tonix Medicines, the commercial subsidiary, markets Zembrace SymTouch and Tosymra for the treatment of acute migraines, and is actively involved in pre-launch activities for TNX-102 SL, including launch strategy and market analysis [2][5][6]

Company Overview - Tonix Pharmaceuticals Holding Corp. is a fully integrated biotechnology company focused on pain management therapies and vaccines for public health challenges [3] - The company has a development portfolio primarily targeting central nervous system (CNS) disorders [3] Key Product Candidates - TNX-102 SL is a product candidate for fibromyalgia management, with an NDA submitted based on two statistically significant Phase 3 studies, and a PDUFA goal date of August 15, 2025 [3] - TNX-102 SL has received Fast Track designation from the FDA for fibromyalgia management [3] - The company is also developing TNX-102 SL for acute stress reaction and acute stress disorder under a Physician-Initiated IND at the University of North Carolina [3] Immunology and Infectious Disease Portfolio - Tonix's immunology portfolio includes TNX-1500, an Fc-modified humanized monoclonal antibody targeting CD40-ligand 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. Department of Defense [3] Commercial Products - Tonix Medicines, the commercial subsidiary, markets Zembrace SymTouch (sumatriptan injection) and Tosymra (sumatriptan nasal spray) for treating acute migraine in adults [3]

Core Insights - Tonix Pharmaceuticals Holding Corp. is set to present a poster at the Annual European Congress of Rheumatology (EULAR) 2025, focusing on its product candidate TNX-102 SL for fibromyalgia treatment [1][3] Company Overview - Tonix is a fully-integrated biotechnology company with a focus on pain management therapies and vaccines for public health challenges [4] - The company is advancing TNX-102 SL, which has a PDUFA goal date of August 15, 2025, for marketing authorization based on two significant Phase 3 studies [4] - TNX-102 SL has received Fast Track designation from the FDA for fibromyalgia management [4] - The company is also developing TNX-102 SL for acute stress reaction and acute stress disorder under a study funded by the U.S. Department of Defense [4] Product Development - Tonix's immunology portfolio includes TNX-1500, a monoclonal antibody targeting CD40-ligand for preventing organ transplant rejection and treating autoimmune diseases [4] - 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 from the U.S. DoD [4] Marketed Products - Tonix Medicines, the commercial subsidiary, markets Zembrace® SymTouch® and Tosymra® for acute migraine treatment [4]

Company Overview - Tonix Pharmaceuticals Holding Corp. is a fully-integrated biotechnology company focused on pain management therapies and vaccines for public health challenges [2] - The company has a development portfolio primarily targeting central nervous system (CNS) disorders [2] Product Development - Tonix's lead product candidate, TNX-102 SL, is aimed at managing fibromyalgia, with an NDA submitted based on two statistically significant Phase 3 studies [2] - The FDA has assigned a PDUFA goal date of August 15, 2025, for a decision on marketing authorization for TNX-102 SL, which has also received Fast Track designation [2] - TNX-102 SL is additionally being developed for acute stress reaction and acute stress disorder under a Physician-Initiated IND at the University of North Carolina [2] Immunology and Infectious Disease Portfolio - The immunology portfolio includes TNX-1500, a monoclonal antibody targeting CD40-ligand for preventing allograft rejection and treating autoimmune diseases [2] - 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. Department of Defense [2] Commercial Products - Tonix Medicines, the commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) and Tosymra® (sumatriptan nasal spray) for treating acute migraine in adults [2][5]

Core Viewpoint - The appointment of Joseph Hand as General Counsel and Executive Vice President of Operations at Tonix Pharmaceuticals is a strategic move as the company prepares for the potential approval of TNX-102 SL for fibromyalgia management next quarter [1][2]. Company Overview - Tonix Pharmaceuticals is a fully-integrated biopharmaceutical company focused on developing therapies for pain management and vaccines for public health challenges, with a particular emphasis on central nervous system (CNS) disorders [3]. - The company is advancing TNX-102 SL, a product candidate for fibromyalgia management, for which a New Drug Application (NDA) has been submitted based on two statistically significant Phase 3 studies [3]. - The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of August 15, 2025, for a decision on marketing authorization for TNX-102 SL, which has also received Fast Track designation [3]. Leadership Experience - Joseph Hand brings over 20 years of strategic legal and business leadership experience in the biopharmaceutical industry, including nearly a decade at Celgene Corporation, where he held senior executive positions [1][2]. - At Celgene, Mr. Hand was involved in significant transactions, including the $74 billion acquisition by Bristol Myers Squibb and the $13.4 billion divestiture of Otezla to Amgen [2]. Strategic Importance - The addition of Mr. Hand is seen as crucial for driving company growth and operational excellence at a pivotal time in Tonix's history, particularly as it prepares for the launch of TNX-102 SL [2]. - The company aims to position itself for long-term growth while delivering meaningful therapies to patients [3]. Development Portfolio - Tonix's development portfolio includes biologics targeting organ transplant rejection, autoimmunity, and cancer, such as TNX-1500, an Fc-modified humanized monoclonal antibody [3]. - The company is also developing a vaccine for mpox, TNX-801, and has secured a contract with the U.S. Department of Defense for up to $34 million over five years to develop TNX-4200, a broad-spectrum antiviral agent [3].