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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.
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Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) announced the development of TNX-601 ER, an abuse-deterrent, naloxone-free formulation of tianeptine for major depressive disorder (MDD). This once-daily tablet is bioequivalent to existing three-times-a-day antidepressants available in Europe. Tonix plans to initiate a Phase 2 study in Q1 2023, pending FDA approval of its IND application. Tianeptine has shown potential for neuroplasticity enhancement, differentiating its action from traditional antidepressants.
Tonix Pharmaceuticals (Nasdaq: TNXP) announced its participation in the World Orphan Drug Congress USA 2022, scheduled for July 11-13. CEO Seth Lederman will present on TNX-2900, an intranasal therapy aimed at treating hyperphagia in adolescents and young adults with Prader-Willi syndrome, on July 11 at 2:00 p.m. ET. Tonix's clinical-stage pipeline includes investigational therapies for various conditions, such as fibromyalgia and Long COVID. The company continues to focus on developing therapeutics across multiple disease areas, enhancing its visibility in the biopharmaceutical sector.
Tonix Pharmaceuticals (TNXP) announced a new Phase 2 clinical trial design for TNX-1300, an innovative treatment for cocaine intoxication. This single-blind, placebo-controlled study aims to include women and patients who received naloxone to enhance enrollment. TNX-1300, a cocaine esterase, has shown efficacy in previous trials and has received Breakthrough Therapy designation from the FDA, providing potential for 12 years of market exclusivity upon approval. With 505,000 annual emergency room visits related to cocaine use in the U.S., the company believes TNX-1300 could significantly address this public health issue.
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) announced a securities purchase agreement with institutional investors to sell 2.5 million shares of Series A and 500,000 shares of Series B convertible redeemable preferred stock at $9.50 per share, totaling $30 million in gross proceeds. Each preferred share is convertible into common stock at $4.00, contingent upon shareholder approval to increase common stock authorization from 50 million to 150 million. The offering is expected to close on June 24, 2022. A.G.P./Alliance Global Partners is the placement agent for this offering.
Tonix Pharmaceuticals (Nasdaq: TNXP) announced the publication of a study demonstrating the enhanced analgesic effects of intranasal oxytocin when combined with magnesium (Mg2+) in animal models. This patented technology underpins their drug candidates, TNX-1900 for migraine prevention and TNX-2900 for treating hyperphagia in Prader-Willi syndrome. The issued patents are expected to ensure market exclusivity until 2036. The CEO stated that the magnesium-enhanced formulation may eliminate dose-related analgesic inconsistencies, potentially offering a non-addictive treatment alternative for migraine and craniofacial pain.
Tonix Pharmaceuticals (Nasdaq: TNXP) announced the opening of its new 45,000 sq ft Advanced Development Center (ADC) in North Dartmouth, Massachusetts, on June 21, 2022. The facility will enhance the company's ability to manufacture clinical quality vaccines for infectious diseases such as monkeypox, smallpox, and COVID-19. The ADC includes state-of-the-art bioreactors and is designed to support U.S. pandemic preparedness. With the capability to employ 70 staff, this facility is a significant step toward accelerating vaccine development and production.
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) unveiled promising data on its TNX-1500 monoclonal antibody at the 2022 American Transplant Congress. The research, conducted by Massachusetts General Hospital, shows that TNX-1500 effectively prevents organ transplant rejection in non-human primates, demonstrating both efficacy and safety. Tonix's CEO highlighted the need for improved treatments in this area, as no effective humanized anti-CD40L antibody exists yet. The company is actively moving into Phase 1 studies for TNX-1500 and continues its development approach across various therapeutic areas.
Tonix Pharmaceuticals (Nasdaq: TNXP) announced an oral presentation highlighting the activity of Wnt/β-Catenin signaling pathway inhibitors against SARS-CoV-2. Presented by Dr. Tom Hobman at the Canadian Society for Virology, the research revealed that these inhibitors reduced lung infection in an animal model. The presentation included promising data on these drugs, some of which have been studied in humans or are FDA approved. Tonix aims to advance these candidates towards clinical testing, indicating a strategic focus on broad-spectrum antiviral development.
Tonix Pharmaceuticals (Nasdaq: TNXP) announced a successful presentation of preclinical data for its vaccine TNX-801 at the 4th Symposium of the Canadian Society for Virology on June 5, 2022. The study demonstrated that all vaccinated macaques achieved sterilizing immunity against monkeypox following exposure. The data, presented by researchers from Tonix and the University of Alberta, highlights the vaccine's potential to combat rising monkeypox cases globally. TNX-801 is based on synthetic horsepox and aims to provide protection against both monkeypox and smallpox.
Tonix Pharmaceuticals (Nasdaq: TNXP) will present at the 2022 BIO International Convention scheduled for June 13-16 in San Diego, CA. The presentation is set for June 13 at 3:45 p.m. PT. Tonix focuses on developing therapeutics in areas such as central nervous system disorders and infectious diseases. Key projects include TNX-102 SL for fibromyalgia and Long COVID, TNX-1300 for cocaine intoxication, and vaccines for smallpox and COVID-19. As a clinical-stage biopharmaceutical company, Tonix's product candidates are investigational and have not yet received FDA approval.
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