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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 (Nasdaq: TNXP) has licensed technology from Inserm for oxytocin-based treatments targeting Prader-Willi syndrome and non-organic failure to thrive. The co-exclusive license expands Tonix's intranasal potentiated oxytocin program with the new candidate TNX-2900. This technology is projected to provide market exclusivity until 2031 across the U.S. and Europe. Prader-Willi syndrome, affecting approximately 1 in 15,000 births, lacks approved treatments. Tonix aims to pursue FDA Orphan Drug and Fast Track designations for TNX-2900, addressing the disorder's critical health challenges.
Tonix Pharmaceuticals, a clinical-stage biopharmaceutical company, announced that its CEO, Seth Lederman, M.D., will participate in the BIO CEO & Investor Digital Conference from February 16-18, 2021. The presentation will be available on demand for registered participants and can later be accessed on the company's website. Tonix focuses on developing therapies for central nervous system and immunology conditions. Its lead candidate, TNX-102 SL, is in mid-Phase 3 trials for fibromyalgia, while TNX-1800 aims to provide protection against COVID-19.
Tonix Pharmaceuticals Holdings Corp. (NASDAQ: TNXP) announced the closing of a registered direct offering, generating approximately $70.0 million in gross proceeds before expenses. The company sold 58,333,334 shares of common stock at $1.20 per share, with A.G.P./Alliance Global Partners acting as the sole placement agent. The offering was conducted under effective shelf registration statements filed with the SEC. Tonix focuses on the development of therapies for CNS and immunology conditions, with several candidates in clinical stages, including TNX-102 SL for fibromyalgia and TNX-1800 for COVID-19.
Tonix Pharmaceuticals Holdings Corp. (NASDAQ: TNXP) announced a securities purchase agreement with institutional investors for the sale of 58,333,334 shares of common stock at $1.20 per share, totaling approximately $70 million in gross proceeds. The registered direct offering is expected to close around February 9, 2021, pending customary conditions. A.G.P./Alliance Global Partners acts as the sole placement agent. This offering is made under effective shelf registration statements filed with the SEC.
Tonix Pharmaceuticals (Nasdaq: TNXP) announced FDA guidance on its pre-investigational new drug (IND) meeting for TNX-2100, a diagnostic skin test to measure T cell immunity to SARS-CoV-2. This test aims to support COVID-19 diagnosis, public health surveillance, and vaccine trials. TNX-2100 utilizes three synthetic peptide mixtures to elicit a delayed-type hypersensitivity reaction, providing a cost-effective and timely method for assessing T cell responses. The company plans to file the IND application in Q2 2021 and begin clinical trials in H2 2021 pending FDA clearance.
Tonix Pharmaceuticals (Nasdaq: TNXP) announced that a patent application for TNX-1500, a monoclonal antibody targeting CD40-ligand, has been published by the World Intellectual Property Organization. This patent could provide U.S. patent coverage until 2040. TNX-1500 is designed to minimize thrombosis risks while maintaining efficacy, aiming to treat organ transplant rejection and autoimmune disorders. The company anticipates GMP production of TNX-1500 by Q3 2021. Tonix's development strategy leverages prior clinical insights, addressing significant treatment gaps in this area.
Tonix Pharmaceuticals Holdings Corp. (NASDAQ: TNXP) announced the completion of a registered direct offering, generating gross proceeds of $40 million. The company sold 50 million shares at $0.80 per share, facilitated by A.G.P./Alliance Global Partners as the sole placement agent. This offering utilized effective shelf registration statements previously filed with the SEC. Tonix, focused on developing CNS and immunology therapeutics, is advancing its lead candidate, TNX-102 SL, through mid-Phase 3 trials and anticipates interim results in Q2 2021.
Tonix Pharmaceuticals Holdings Corp. (NASDAQ: TNXP) announced a registered direct offering of 50 million shares at $0.80 per share, generating gross proceeds of $40 million before expenses. Closing is expected by January 13, 2021, pending customary conditions. The offering will utilize effective shelf registration statements filed with the SEC. Tonix focuses on developing treatments for central nervous system and immunology conditions, with ongoing clinical trials, including the mid-Phase 3 study for TNX-102 SL for fibromyalgia and TNX-1800, a COVID-19 vaccine candidate.
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) announced that CEO Seth Lederman will present at four virtual conferences from January 11 to January 14, 2021. These events include the H.C. Wainwright BioConnect Conference and the Biotech Showcase 2021, both offering on-demand presentations. The Sidoti Winter Virtual Investor Conference is scheduled for January 13, 2021, at 9:15 a.m. ET, followed by the ICR Conference 2021 on January 14, 2021, also at 9:15 a.m. ET. Webcasts will be available on the company’s website.
Tonix Pharmaceuticals (Nasdaq: TNXP) has expanded its collaboration with Massachusetts General Hospital to further research TNX-1500, a monoclonal antibody aimed at preventing organ transplant rejection. The new focus will be on kidney transplantation, building on existing studies in heart transplantation. TNX-1500 is designed to target CD40-ligand and reduce the risk of thrombosis associated with previous generations. The company emphasizes the potential of TNX-1500 in treating autoimmune diseases, including rheumatoid arthritis and systemic lupus erythematosus.