Welcome to our dedicated page for Tonix Pharmaceuticals Holding news (Ticker: TNXP), a resource for investors and traders seeking the latest updates and insights on Tonix Pharmaceuticals Holding stock.
Tonix Pharmaceuticals Holding Corp. (symbol: TNXP) is a pioneering biopharmaceutical company dedicated to developing, licensing, and commercializing innovative therapeutics to treat and prevent human diseases. With a focus on central nervous system (CNS) disorders, Tonix is at the forefront of addressing major public health challenges.
One of Tonix's key projects is Tonmya, aimed at treating PTSD, which is currently in advanced stages of development. Additionally, the company is working on TNX-601 (tianeptine oxalate), a daytime treatment for PTSD, and TNX-801, a synthetic version of the horsepox virus, intended as a potential smallpox vaccine, both at the pre-IND (Investigational New Drug) application stage.
The company’s immunology development portfolio includes TNX-1500, a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154), being developed to prevent allograft rejection and treat autoimmune diseases. This portfolio demonstrates Tonix's commitment to addressing both organ transplant rejection and autoimmunity, as well as cancer.
Tonix’s mission to alleviate suffering extends beyond CNS disorders and immunology, as it is also exploring therapeutic solutions for rare and infectious diseases. Their dedication to research and innovation has established partnerships with reputable institutions, such as Massachusetts General Hospital, ensuring that their projects are backed by cutting-edge science and expertise.
For more information, visit Tonix Pharmaceuticals Holding Corp.
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Tonix Pharmaceuticals Holding Corp. (TNXP) announced the positive results from the Phase 3 RESILIENT study of TNX-102 SL for the management of fibromyalgia. The study met its primary endpoint with a statistically significant reduction in daily pain compared to placebo. The results also showed favorable tolerability and side effect profiles, including improvement in female sexual function and no increases in weight or blood pressure. The company plans to submit a New Drug Application to the FDA in the second half of 2024 under the 505(b)(2) regulatory pathway.
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Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) announced positive results from a Phase 3 trial for TNX-102 SL, a non-opioid analgesic, and plans to submit a New Drug Application to the FDA in the second half of 2024. The company also shared updates on its various development candidates for central nervous system disorders, rare diseases, immunology, and infectious diseases, as well as its marketed products Zembrace SymTouch and Tosymra.
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Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) secures $30 million upfront financing with potential for an additional $114 million tied to warrants exercise. The company signed securities purchase agreements with healthcare-focused institutional investors, aiming to raise up to $144 million in gross proceeds through a registered direct offering.
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Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) announced that the Phase 3 RESILIENT study evaluating TNX-102 SL (cyclobenzaprine HCl sublingual tablets) for fibromyalgia met its primary endpoint, demonstrating daily pain reduction over placebo (p = 0.00005) and all six key secondary endpoints were significantly improved. Positive results support planned New Drug Application (NDA) submission to the FDA in the second half of 2024. The study showed statistically significant and clinically meaningful results in improving sleep quality, reducing fatigue, and overall fibromyalgia symptoms and function. TNX-102 SL is a novel, centrally-acting, non-opioid analgesic, designed for once daily use at bedtime for fibromyalgia management. The estimated 6 million to 12 million U.S. adults living with fibromyalgia, the majority of whom are women, could benefit from this treatment.
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Fibromyalgia Therapeutics PLC (FTPL) is set to release topline data from a Registration-Enabling Phase 3 Clinical Trial later this month.
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Tonix Pharmaceuticals Holding Corp. (TNXP) to present at the National Academies of Sciences, Engineering, and Medicine Committee on the Current State of Research, Development, and Stockpiling of Smallpox Medical Countermeasures public meeting. The company's CEO, Dr. Seth Lederman, will participate in a panel discussion on Vaccine Research & Development to inform an evaluation of the current state of smallpox readiness and response measures.
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Tonix Pharmaceuticals Holding Corp. (TNXP) announced that the U.S. FDA has cleared the Investigational New Drug (IND) application to support clinical development of TNX-2900, a proprietary magnesium-enhanced formulation of intranasal oxytocin, to treat Prader-Willi syndrome (PWS) in children and adolescents. The Phase 2 study approved by the IND is a dose-finding study involving approximately 36 PWS patients, and Tonix intends to seek a partner to advance TNX-2900 for PWS in clinical development.
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Tonix Pharmaceuticals Holding Corp. (TNXP) announced that Tonix Management will present and host investor meetings at NobleCon 19 and the December Virtual Investor Summit. The company is a biopharmaceutical company focused on commercializing, developing, discovering, and licensing therapeutics to treat and prevent human disease and alleviate suffering. Tonix's development portfolio includes CNS, rare disease, immunology, and infectious disease product candidates. The company's lead development CNS candidate, TNX-102 SL, is in mid-Phase 3 development for the management of fibromyalgia, with topline data expected in late December 2023. The company's rare disease development portfolio includes TNX-2900 for the treatment of Prader-Willi syndrome. Tonix's immunology development portfolio includes biologics to address organ transplant rejection, autoimmunity, and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. The company's infectious disease pipeline includes TNX-801, a vaccine in development to prevent smallpox and mpox. The infectious disease development portfolio also includes TNX-3900 and TNX-4000, which are classes of broad-spectrum small molecule oral antivirals.
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Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) announced the completion of the clinical phase of the Phase 3 registration-quality, double-blind, placebo-controlled RESILIENT1 study of TNX-102 SL2 (cyclobenzaprine HCl sublingual tablets) 5.6 mg for fibromyalgia management. The study achieved statistical significance (p=0.010) and showed a favorable adverse-event (AE) related discontinuation rate of 4.8% compared to prior studies. TNX-102 SL is a non-opioid analgesic medication designed to improve sleep quality and other fibromyalgia symptoms.
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Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) announced enrollment of the first participant in a Phase 2 study of TNX-1900 for improving bone health in children with autism spectrum disorder (ASD). The study aims to investigate the efficacy and safety of TNX-1900 as a novel therapeutic agent to increase bone density and improve bone structure and strength in children with ASD.
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FAQ
What is the current stock price of Tonix Pharmaceuticals Holding (TNXP)?
The current stock price of Tonix Pharmaceuticals Holding (TNXP) is $0.3831 as of January 24, 2025.
What is the market cap of Tonix Pharmaceuticals Holding (TNXP)?
The market cap of Tonix Pharmaceuticals Holding (TNXP) is approximately 73.1M.
What is the main focus of Tonix Pharmaceuticals Holding Corp.?
Tonix focuses on developing, licensing, and commercializing therapeutics to treat and prevent human diseases, with a primary focus on central nervous system disorders.
What is Tonmya?
Tonmya is a treatment developed by Tonix Pharmaceuticals aimed at addressing PTSD. It is one of the company's key projects.
What are TNX-601 and TNX-801?
TNX-601 (tianeptine oxalate) is a candidate for daytime treatment of PTSD and TNX-801 is a synthetic version of the horsepox virus, intended as a potential smallpox-preventing vaccine.
What is TNX-1500?
TNX-1500 is a humanized monoclonal antibody targeting CD40-ligand, being developed to prevent allograft rejection and treat autoimmune diseases.
Which institutions is Tonix Pharmaceuticals affiliated with?
Tonix has established partnerships with reputable institutions, including Massachusetts General Hospital, to support their research and development projects.
How can I get more information about Tonix Pharmaceuticals?
More information about Tonix Pharmaceuticals can be found on their official website, www.tonixpharma.com.
What areas of disease does Tonix Pharmaceuticals focus on?
Tonix focuses on central nervous system disorders, organ transplant rejection, autoimmunity, cancer, rare diseases, and infectious diseases.
What stage are TNX-601 and TNX-801 in?
Both TNX-601 and TNX-801 are at the pre-IND (Investigational New Drug) application stage.
Who can I contact for investor relations at Tonix Pharmaceuticals?
For investor relations, you can contact Jessica Morris at investor.relations@tonixpharma.com or Peter Vozzo at peter.vozzo@westwicke.com.
Who can I contact for media inquiries at Tonix Pharmaceuticals?
For media inquiries, you can contact Katie Dodge at kdodge@lavoiehealthscience.com.
Tonix Pharmaceuticals Holding Corp.
Nasdaq:TNXP
TNXP Rankings
TNXP Stock Data
73.08M
186.60M
0.17%
0.23%
5.48%
Biotechnology
Pharmaceutical Preparations
United States of America
CHATHAM