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.
On March 3, 2021, Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) announced it has regained compliance with Nasdaq's minimum bid price requirement. The company confirmed its shares closed above $1.00 for 20 consecutive business days, satisfying the listing criteria. Tonix focuses on developing treatments for CNS and immunology conditions, with its lead candidate TNX-102 SL in mid-Phase 3 trials for fibromyalgia. The company expects interim data from another Phase 3 trial, RALLY, in Q3 2021, and efficacy data for its COVID-19 vaccine candidate, TNX-1800, in Q1 2021.
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.