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 a 1-for-32 reverse stock split effective May 17, 2022. This measure aims to raise the per-share trading price to meet NASDAQ's minimum $1.00 bid price requirement for continued listing. The reverse split will reduce authorized shares from 1.6 billion to 50 million and will also affect outstanding warrants and stock options. Shareholders will not receive cash for fractional shares. The company is engaged in developing therapeutics for various diseases, including fibromyalgia and Long COVID.
Tonix Pharmaceuticals (NASDAQ: TNXP) announced key developments and financial results for Q1 2022. The company initiated enrollment for its Phase 3 trial of TNX-102 SL for fibromyalgia, expecting interim results in Q1 2023. The FDA cleared the IND for TNX-102 SL targeting Long COVID, with a Phase 2 trial set to begin soon. Financially, Tonix reported $140 million in cash, down from $178 million at the end of 2021, with Q1 cash used for operations rising to $31 million. R&D expenses were $18.4 million, leading to a net loss of $26.4 million, or $0.05 per share.
Tonix Pharmaceuticals (Nasdaq: TNXP) announced that its Chief Operating Officer, Jessica Morris, will present at the 2022 Q2 Investor Summit on May 4, 2022, at 11:00 a.m. ET in New York. Interested investors can arrange meetings with management through the conference coordinator. A webcast of the presentation will be accessible on Tonix's website under the IR Events tab. Tonix focuses on developing therapeutics across various sectors including immunology, infectious disease, and CNS disorders. The company plans to initiate several clinical trials for its pipeline products in 2022.
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a clinical-stage biopharmaceutical company, announced that CEO Seth Lederman will present at B. Riley Securities' 2022 Virtual Neuro & Ophthalmology Conference on April 27, 2022, at 1:00 p.m. ET. A webcast will be available on the company’s website.
Tonix focuses on developing therapeutics for immunology, rare diseases, infectious diseases, and CNS conditions, with several investigational drugs in the pipeline, including TNX-1500 for autoimmune diseases and TNX-2900 for Prader-Willi syndrome, both expecting clinical trials in 2022.
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) announced findings from a study involving over 50,000 Long COVID patients, revealing that over 40% exhibited fibromyalgia-like multi-site pain symptoms. The study highlights that 36% of these patients used opioids, a rate that increased with additional symptoms like fatigue and insomnia. The FDA has cleared an IND application for TNX-102 SL, which will enter a Phase 2 clinical trial targeting this specific symptom set in Long COVID. The trial is set to commence in the second quarter of 2022.
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) announced that CEO Seth Lederman will present at NobleCon18, taking place from April 19-21, 2022, in Hollywood, Florida. Lederman's presentation is scheduled for April 21 at 9:30 a.m. ET in the Seminole Ballroom C of the Hard Rock Hotel & Casino. A webcast will be available on the Tonix website starting April 22. The company focuses on developing therapeutics for various conditions, including autoimmune diseases and infectious diseases, with several product candidates at different stages of clinical development.
Tonix Pharmaceuticals (Nasdaq: TNXP) has commenced its Phase 3 RESILIENT study for TNX-102 SL, targeting fibromyalgia management. This pivotal study follows positive results from the earlier Phase 3 RELIEF study, which showed significant efficacy (p=0.010), while the subsequent RALLY study did not achieve significance (p=0.115). An interim analysis of RESILIENT is anticipated in Q1 2023. The investigational TNX-102 SL aims to provide a non-addictive treatment option for fibromyalgia, a condition afflicting an estimated 6-12 million adults in the U.S.
Tonix Pharmaceuticals (Nasdaq: TNXP) announced FDA clearance for a Phase 2 clinical trial of TNX-102 SL, targeting Long COVID patients with symptoms overlapping fibromyalgia. This trial will evaluate the efficacy of TNX-102 SL, a sublingual formulation, in treating multi-site pain associated with Long COVID. The 14-week study aims to enroll approximately 470 patients across 30 sites, with results anticipated to inform on pain intensity changes. Long COVID affects over 30% of those recovering from COVID-19, presenting a significant health concern.
Tonix Pharmaceuticals (Nasdaq: TNXP) has announced a new preclinical research agreement with Kansas State University to advance the development of TNX-2300, a live virus vaccine aimed at protecting against COVID-19. This vaccine uses a bovine parainfluenza virus vector platform and aims to enhance T cell immunity through the co-expression of the CD40-ligand. Initial studies show that this vaccine could elicit strong and durable immunity. The research is directed by Dr. Waithaka Mwangi, and an exclusive license for the vaccine's clinical and commercial use has been granted to Tonix.
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) announced that its CEO Seth Lederman will present at the 2022 Virtual Growth Conference, hosted by Maxim Group LLC from March 28-30, 2022. The presentations will be available on-demand through the conference portal. Tonix is focused on developing therapeutics for conditions such as fibromyalgia and Long COVID, with its lead candidates, TNX-102 SL and TNX-1300, expected to enter new phases of clinical trials in the first half of 2022. More information can be found on Tonix's website.