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. (Nasdaq: TNXP) generates a steady flow of news as a fully integrated, commercial-stage biotechnology company with both marketed products and a broad development pipeline. News coverage for Tonix often centers on its FDA-approved fibromyalgia treatment TONMYA, its acute migraine products Zembrace SymTouch and Tosymra, and updates on clinical and regulatory milestones across central nervous system, immunology, rare disease and infectious disease programs.
Investors following TNXP news can expect announcements on commercial launches, market access decisions, and distribution arrangements for TONMYA, as well as prescription trends and formulary placements for its migraine therapies. The company also regularly reports progress on TNX-102 SL in indications such as acute stress-related conditions and major depressive disorder, including IND clearances and the design of potentially pivotal Phase 2 studies.
Tonix’s immunology and infectious disease work contributes additional news items, including collaborations with academic centers like Massachusetts General Hospital for TNX-1500 in kidney transplantation, and development plans for TNX-4800, a monoclonal antibody designed for seasonal prevention of Lyme disease. Licensing transactions, such as the acquisition of TNX-4900 for chronic neuropathic pain from Rutgers University, and government-supported projects like the DTRA-backed antiviral TNX-4200, are also common themes in company press releases.
This TNXP news page aggregates company-issued updates and related coverage so readers can quickly review developments in Tonix’s commercial operations, clinical pipeline, financing activities, and strategic collaborations. For investors and observers tracking biotech catalysts, revisiting this page provides a concise way to monitor how Tonix’s programs and capital markets actions evolve over time.
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) announced that CEO Seth Lederman will present at the Virtual Q3 Investor Summit on August 16, 2022, at 9:30 a.m. ET. Investors can schedule meetings with management during the conference. The presentation will be available via webcast.
Tonix is a clinical-stage biopharmaceutical company focused on developing therapies for CNS disorders, rare diseases, and infectious diseases. Their lead candidate, TNX-102 SL, is in mid-Phase 3 development for fibromyalgia and also targets Long COVID. Additional products are in various stages of development for other conditions.
Tonix Pharmaceuticals announced the receipt of a Cooperative Agreement grant from the National Institute on Drug Abuse (NIDA) to develop TNX-1300, a treatment for cocaine intoxication. This follows the drug's Breakthrough Therapy designation by the FDA, paving the way for a Phase 2 clinical trial expected to start in Q4 2022. Cocaine intoxication, which saw over 24,900 overdose deaths in 2021 in the U.S., currently lacks specific treatments. TNX-1300 aims to target the cause of intoxication, offering potential advantages over existing therapies.
Tonix Pharmaceuticals (Nasdaq: TNXP) announced the issuance of U.S. Patent 11,389,473 on July 19, 2022, for its intranasal magnesium-containing oxytocin formulations targeting migraine treatment, valid until 2036. With FDA IND clearance, a Phase 2 study for TNX-1900, aimed at chronic migraine prevention, is scheduled to commence in the second half of 2022. Approximately four million Americans suffer from chronic migraine, presenting a significant market opportunity for Tonix's innovative treatment approach.
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) has announced a collaboration with the Kenya Medical Research Institute (KEMRI) to initiate a Phase 1 clinical study for TNX-801, a vaccine targeted at monkeypox and smallpox, expected to start in the first half of 2023. The partnership responds to the World Health Organization's declaration of monkeypox as a global health emergency. TNX-801 is a live virus vaccine with reduced virulence and aims to provide durable immunity without requiring ultra-cold storage, potentially addressing the growing monkeypox issue in Africa.
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) announced the appointment of Sina Bavari, Ph.D. as Executive Vice President, Infectious Disease Research and Development. Dr. Bavari will lead the company's infectious disease pipeline, overseeing operations at the Frederick, MD R&D Center. With a strong background in managing infectious disease programs, he aims to expedite development in vaccines for monkeypox, smallpox, and COVID-19. Tonix also highlighted its ongoing clinical trials for various therapeutic candidates, reinforcing its commitment to addressing critical health issues globally.
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.