Welcome to our dedicated page for Tonix Pharmaceut news (Ticker: TNXP), a resource for investors and traders seeking the latest updates and insights on Tonix Pharmaceut stock.
Tonix Pharmaceuticals Holding Corp. develops and commercializes biotechnology products for central nervous system disorders, immunology, infectious diseases and rare diseases. Company news centers on TONMYA, an FDA-approved cyclobenzaprine HCl sublingual tablet for fibromyalgia in adults, along with marketed acute migraine products Zembrace SymTouch and Tosymra.
Recurring updates also cover Tonix’s development pipeline, including TNX-4800, a long-acting anti-Borrelia OspA human monoclonal antibody for Lyme disease prophylaxis; TNX-1900 intranasal potentiated oxytocin for craniofacial pain conditions; TNX-1700 and TNX-4700 immuno-oncology programs; TNX-801 vaccine research; and TNX-1500 for prevention of kidney transplant rejection. Other company developments include scientific presentations, clinical and preclinical data, commercial access arrangements, operating results, capital-structure disclosures and governance matters.
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.
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) has acquired a 44-acre site in Hamilton, Montana, to build a commercial-scale vaccine manufacturing facility. This site complements their 40,000 square foot Advanced Development Center in Massachusetts. The facilities aim to support the development of Tonix's COVID-19 vaccine candidate, TNX-1800, and other vaccines. CEO Seth Lederman emphasizes the need for U.S.-based vaccine production post-pandemic. Tonix's approach involves live-virus vaccines for durable immunity. Efficacy data is expected in early 2021.
Tonix Pharmaceuticals (Nasdaq: TNXP) announced the acquisition of an exclusive license for technology from the University of Geneva that uses oxytocin to treat insulin resistance and obesity, through Katana Pharmaceuticals. This agreement enhances Tonix's TNX-1900 program by addressing cardiometabolic syndromes and provides patent protection until 2031 in the U.S. and Europe. The technology showed promise in improving lipid metabolism and insulin sensitivity, with potential applications for treating chronic migraines.
Tonix Pharmaceuticals announced topline results from its Phase 3 RECOVERY study of TNX-102 SL for treating PTSD. The primary endpoint did not achieve statistical significance (P=0.343), consistent with interim analysis. However, secondary endpoints showed encouraging activity with improvements in Clinical Global Impression - Severity (P=0.024) and Patient Global Impression of Change (P=0.007). The treatment was well tolerated without new safety signals. The company plans to pursue TNX-102 SL for sleep disturbance in PTSD, a prevalent condition affecting nearly 12 million adults in the U.S.
Tonix Pharmaceuticals (Nasdaq: TNXP) announced that its drug TNX-102 SL achieved a statistically significant pain reduction of p=0.01 in fibromyalgia patients during the Phase 3 RELIEF study. The trial involved 503 participants and demonstrated TNX-102 SL's potential to improve sleep and reduce fatigue. The company plans to submit a New Drug Application (NDA) to the FDA in 2022 if the ongoing RALLY study yields favorable results. The 5.6 mg dose was well tolerated, with no new safety signals reported, highlighting its promise as a non-opioid treatment for fibromyalgia.