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]

Mr. Hunter brings more than 40 years of experience building and leading commercial organizations in the biopharmaceutical industry, including leadership roles at Validus Pharmaceuticals, Relialab and Novartis Led launch of Tonix Medicines, acquisition of migraine assets Zembrace® SymTouch® and Tosymra®, and recruitment of commercial leadership team Appointment strengthens commercial strategy and governance as Tonix prepares for potential launch of TNX-102 SL for fibromyalgia this year CHATHAM, N.J., June 13 ...

* Tonix's product development candidates are investigational new drugs or biologics; their efficacy and safety have not been established and have not been approved for any indication. Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. All other marks are property of their respective owners. This press release and further information about Tonix can be found at www.tonixpharma.com. CHATHAM, N.J., June 10, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (To ...

A copy of the Company's poster presentation will be available under the Scientific Presentations tab of the Tonix website at www.tonixpharma.com following the conference. Additional meeting information can be found on the EULAR website here. CHATHAM, N.J., June 05, 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 a poster presentation at ...

CHATHAM, N.J., May 22, 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 that Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals participated in a fireside chat at A.G.P.’s Annual Healthcare Company Showcase. A webcast of the presentation can be found under the IR Events tab of the Tonix website at www.tonixpharma.com. Tonix Pharmaceuticals H ...

Core Insights - Tonix Pharmaceuticals is advancing TNX-1700, a combination therapy involving TFF2 and anti-PD1 antibody, showing potential in enhancing anti-tumor immune responses in gastric and colorectal cancers [1][2] - The company presented promising preclinical data at the AACR 2025 Annual Meeting, indicating that TFF2-mediated CXCR4 partial agonism is more effective than antagonism in reducing gastric cancer in animal models [1][2] Company Overview - Tonix Pharmaceuticals is a fully-integrated biopharmaceutical company with a focus on developing therapies for pain management, immunology, and infectious diseases [7] - The company is also working on TNX-102 SL for fibromyalgia, which has received Fast Track designation from the FDA, with a PDUFA goal date of August 15, 2025 [7] Research and Development - TNX-1700 is being developed under a license from Columbia University, with Dr. Timothy Wang as the inventor, who has demonstrated the protective role of TFF2 against cancer development [3] - The research indicates that TFF2 can suppress immunosuppressive neutrophils (PMN-MDSCs) and enhance the activation of CD8+ T cells, which are crucial for anti-tumor immunity [2][3] Clinical Implications - The combination of TFF2 and anti-PD1 therapy has shown promise in reducing immunosuppression in the tumor microenvironment, potentially leading to improved treatment outcomes for patients with gastric cancer [2] - The correlation between TFF2 levels and PMN-MDSCs in gastric cancer patients suggests a potential biomarker for treatment efficacy [2]

TNX-801 is a single-dose, live virus vaccine in development to protect against mpox and smallpox TNX-801 protects immunocompromised animals from a lethal challenge with clade IIa monkeypox virus Durability of TNX-801 vaccination shown by six-month protection of animals from a lethal challenge with rabbitpox Tolerability of TNX-801 demonstrated in immunocompromised animals by no spreading to blood or tissues, even at high doses CHATHAM, N.J., April 24, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding C ...

CHATHAM, N.J., April 01, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP), a biopharmaceutical company with a portfolio of marketed products and a pipeline of development candidates, today announced the launch of TONIX ONE™, a fully-integrated digital platform designed to help patients better understand and manage their migraine condition. Through a series of strategic partnerships with UpScript Telemedicine, ProModRx, Blink Health and a leading mobile application specializing in d ...