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 Holding Corp. (Nasdaq: TNXP) announced two oral presentations at the 2022 American Transplant Congress taking place June 4-8, 2022, in Boston, MA. The presentations, led by faculty from Massachusetts General Hospital, focus on TNX-1500, an Fc-modified anti-CD40L monoclonal antibody aimed at preventing organ transplant rejection. Key studies include:
- Long-Term Rejection Free Renal Allograft Survival - June 5, 6:20 PM
- Prolongs Nonhuman Primate Cardiac Allograft Survival - June 7, 5:50 PM
Details are available on the company's website.
Tonix Pharmaceuticals announced a license agreement with the University of Alberta to develop broad-spectrum antiviral drugs targeting SARS-CoV-2 and other viruses. The collaboration focuses on Wnt/β-Catenin pathway inhibitors, which have shown promise in reducing virus replication and enhancing interferon production. Tonix's antiviral efforts align with their broader goal of pandemic preparedness. The company is also advancing multiple product candidates across its pipeline, including treatments for fibromyalgia, Long COVID, and cocaine intoxication.
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.