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. announces the publication of a research paper in the Journal Pain, revealing that patients with pre-existing chronic overlapping pain conditions (COPCs) had an increased risk of being diagnosed with symptoms of Long COVID. The study found that COPCs and Long COVID likely result from the same or similar brain processes, and Long COVID can be conceptualized as a new onset COPC or an exacerbation of a pre-existing COPC. The company is studying TNX-102 SL for the management of fibromyalgia and management of fibromyalgia-type Long COVID. Tonix has plans to submit an NDA to the U.S. Food and Drug Administration in the second half of 2024 under the 505(b)(2) regulatory pathway for Tonmya for the management of fibromyalgia.
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Tonix Pharmaceuticals Holding Corp. announced positive results from two Phase 3 studies for Tonmya (TNX-102 SL) in managing fibromyalgia, with plans to submit a New Drug Application to the FDA in the second half of 2024. The studies showed statistically significant reduction in daily pain and improvement in sleep quality, fatigue, and overall fibromyalgia symptoms. The FDA conditionally accepted the trade name Tonmya for TNX-102 SL, marking a significant step forward for the company in offering the first FDA-approved drug for fibromyalgia patients in more than a decade.
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Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) announced a key opinion leader (KOL) webinar to discuss the positive Phase 3 data of TNX-102 SL for the management of fibromyalgia. The webinar will feature two esteemed thought leaders in the field of fibromyalgia and will be hosted by Alliance Global Partners. The webinar will take place on January 31, 2024, at 1:00 p.m. ET.
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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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FAQ
What is the current stock price of Tonix Pharmaceuticals Holding (TNXP)?
The current stock price of Tonix Pharmaceuticals Holding (TNXP) is $0.19 as of November 22, 2024.
What is the market cap of Tonix Pharmaceuticals Holding (TNXP)?
The market cap of Tonix Pharmaceuticals Holding (TNXP) is approximately 38.2M.
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
38.16M
186.60M
0.17%
0.23%
5.48%
Biotechnology
Pharmaceutical Preparations
United States of America
CHATHAM