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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) has successfully closed a registered direct offering, generating approximately $10.5 million before fees. The company issued 20,940,000 shares at $0.50 per share, raising its total outstanding shares to 125,743,906. A.G.P./Alliance Global Partners acted as the placement agent. This offering was made under an effective shelf registration statement with the SEC. Tonix focuses on developing therapies for CNS and immunology, with its lead candidates addressing COVID-19 and fibromyalgia.
Tonix Pharmaceuticals Holdings Corp. (NASDAQ: TNXP) has announced a securities purchase agreement with institutional investors for the sale of 20,940,000 shares at $0.50 per share, totaling approximately $10.5 million in gross proceeds. The registered direct offering is set to close on or about July 15, 2020. A.G.P./Alliance Global Partners is acting as the sole placement agent. Tonix is focused on developing treatments for CNS disorders and immunology, including vaccines for COVID-19 and smallpox, with upcoming data from various clinical trials expected in late 2020.
Tonix Pharmaceuticals (NASDAQ: TNXP) has entered a preclinical research agreement with Kansas State University to develop TNX-2300, a live replicating vaccine for COVID-19 based on bovine parainfluenza virus. This vaccine aims to stimulate T cell immunity through the CD40-ligand, promoting durable immunity and potentially preventing virus transmission. TNX-2300 is the second live viral vaccine platform for the company, complementing its lead candidate TNX-1800, which is based on horsepox virus. Both vaccines are in preclinical development stages.
Tonix Pharmaceuticals (Nasdaq: TNXP) achieved target enrollment of approximately 470 participants in its Phase 3 RELIEF trial for TNX-102 SL, a non-opioid treatment for fibromyalgia, ahead of schedule. An interim analysis of 50% of participants is expected in September 2020, with topline data anticipated in Q4 2020. The RELIEF study is designed to assess the efficacy and safety of TNX-102 SL, with results expected to provide insights into a new treatment option for the fibromyalgia community.
Tonix Pharmaceuticals (Nasdaq: TNXP) announced plans to acquire a 40,000 sq. ft. facility in Massachusetts to establish an Advanced Development Center for R&D focused on immunology candidates, including vaccines for COVID-19. The new center will enhance Tonix's process and analytical development capabilities and is expected to be operational in 2022. Current collaborations with Southern Research and FUJIFILM Diosynth Biotechnologies for preclinical testing and manufacturing of TNX-801 and TNX-1800 vaccines will continue. Preclinical results for TNX-1800 are anticipated in Q4 2020.
Tonix Pharmaceuticals (Nasdaq: TNXP) announced accelerated enrollment for its Phase 3 RELIEF study of TNX-102 SL, aiming to report topline results in Q4 2020, earlier than previously expected. The study targets fibromyalgia, involving approximately 470 participants across 40 U.S. sites. An interim analysis of the first half of participants is anticipated in September 2020. This progress highlights Tonix’s efforts to provide a non-addictive treatment option for fibromyalgia, potentially addressing a significant market need.
Tonix Pharmaceuticals (Nasdaq: TNXP) announced an expansion of its collaboration with Southern Research to study T cell immune responses to SARS-CoV-2 in COVID-19 recovered or asymptomatic individuals. This research supports the development of TNX-1800, a live replicating virus vaccine aimed at eliciting T cell immunity. Data from this study will aid in interpreting upcoming animal trials and human studies. TNX-1800 aims for single-dose immunity without adjuvants and is expected to be manufactured on conventional systems, potentially allowing glass-sparing distribution.
Tonix Pharmaceuticals (Nasdaq: TNXP) announced that preclinical results of TNX-1700 will be presented at the AACR Virtual Annual Meeting II from June 22-24, 2020. The poster titled ‘Stabilized recombinant trefoil factor 2 (TFF2-CTP) enhances anti-tumor activity of PD-1 blockade in mouse models of colorectal cancer’ will showcase the enhancement of PD-1 blockade efficacy in colorectal cancer. The company focuses on developing drugs in CNS and immunology with ongoing programs like TNX-102 SL for fibromyalgia and TNX-1800 for COVID-19 protection, expecting data in Q4 2020.
Tonix Pharmaceuticals (Nasdaq: TNXP) announced the acquisition of migraine and pain treatment technologies from Trigemina, Inc., along with a license from Stanford University. The main asset, TNX-1900, is an intranasal oxytocin solution with promising preclinical results in migraine prevention and pain management. Tonix aims to position TNX-1900 as a non-addictive alternative to opioids. With oxytocin linked to reduced headache frequency, the targeted delivery method may enhance efficacy and safety, making it a notable asset in their portfolio.
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) announced participation in two virtual investor conferences in June 2020. The first event, 2020 BIO Digital, will be held from June 8-12, with presentations available on demand. The second event is the Virtual Summer Summit on June 10, where Tonix's presentation is scheduled for 2:45 p.m. ET. The company focuses on developing drugs for pain, psychiatric conditions, and infectious diseases, including a COVID-19 vaccine candidate, TNX-1800. Tonix’s advanced treatments target fibromyalgia and PTSD, with important trial results expected soon.
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