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.
On March 23, 2023, Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) presented at the Rare Disease Innovation and Partnership Summit. The presentation focused on TNX-2900, an intranasal potentiated oxytocin being developed to treat hyperphagia in adolescents and young adults with Prader-Willi Syndrome (PWS). This formulation, enhanced with magnesium, aims to improve receptor activation for better appetite control. The FDA has granted Orphan Drug designation for TNX-2900. Currently, there are no approved treatments for hyperphagia related to PWS, making this development significant for affected patients.
On March 23, 2023, Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) announced that CEO Seth Lederman will present at the 5th International Congress on Controversies in Fibromyalgia. The presentation will cover the efficacy and safety of TNX-102 SL for fibromyalgia, based on results from the randomized RELIEF trial. It is scheduled for March 30, 2023, at 5:10 p.m. CEST in Vienna, Austria. Additionally, a poster presentation will accompany the oral presentation. The company’s abstract will be published in a special issue of Clinical and Experimental Rheumatology. Tonix is focused on developing novel therapeutics, with interim data for TNX-102 SL expected in Q2 2023.
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) announced that Jessica Morris, COO, will present at the Virtual March Investor Summit on March 29, 2023, at 9:00 a.m. ET. Interested investors can arrange meetings through the conference coordinator. The presentation will be available via webcast on the Tonix website. Tonix focuses on developing therapeutics for CNS, rare diseases, immunology, and infectious diseases. Their lead candidate, TNX-102 SL, is in mid-Phase 3 for fibromyalgia, with interim data due in Q2 2023. Additionally, TNX-1300 for cocaine intoxication and TNX-801 vaccine for smallpox are among the key products in development.
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) will present at the Rare Disease Innovation and Partnership Summit from March 21-23, 2023, in Philadelphia. Dr. Herbert Harris will discuss TNX-2900, an intranasal treatment aimed at managing hyperphagia in adolescents and young adults with Prader-Willi Syndrome. The presentation is scheduled for March 23, 2023, from 1:15 p.m. to 1:45 p.m. ET. TNX-2900 holds an Orphan Drug designation by the FDA, indicating its potential significance in addressing this rare condition. Tonix's broader portfolio includes various candidates addressing CNS, rare diseases, and infectious diseases.
Tonix Pharmaceuticals (Nasdaq: TNXP) has initiated the Phase 2 UPLIFT study for TNX-601 ER, an extended-release formulation of tianeptine, targeting major depressive disorder (MDD). With a planned enrollment of 300 participants across 30 U.S. sites, the study aims to analyze safety and efficacy, with interim results anticipated in Q4 2023. TNX-601 ER is designed to enhance neuroplasticity, presenting a novel approach to MDD treatment compared to traditional antidepressants. Tianeptine has been used internationally for over 30 years and offers a potentially improved safety profile with minimal side effects.
Tonix Pharmaceuticals (Nasdaq: TNXP) announced its financial results for Q4 and the full year 2022, reporting a net loss of $116.9 million for the year, equating to a loss of $3.27 per share. As of December 31, 2022, the company had approximately $120.2 million in cash and cash equivalents. The company is currently conducting an interim analysis of its Phase 3 fibromyalgia trial, with topline data expected in Q4 2023. Additionally, two potentially pivotal Phase 2 trials are set for interim analyses in the same quarter for TNX-1900 in chronic migraine and TNX-601 ER in depression. This expansion is aimed at addressing significant unmet medical needs.
Tonix Pharmaceuticals Holding Corp. (TNXP) announced preclinical results of its drug, mTNX-1700, which shows enhanced anti-tumor activity in colorectal cancer models when combined with anti-PD-1 therapy. Presented at the Keystone Symposia on March 6, 2023, data demonstrated that mTNX-1700 activates CD8+ T cells and inhibits MDSCs, improving immune response. The company is developing mTNX-1700 as a treatment for colorectal and gastric cancers, and has exclusive U.S. market rights until April 2, 2033, based on licensing from Columbia University. Further studies in humans are planned to assess the drug's potential to modify the tumor microenvironment.
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) announced the appointment of R. Newcomb Stillwell to its Board of Directors, effective March 15, 2023. Mr. Stillwell brings nearly 40 years of corporate law experience from Ropes & Gray LLP, where he advised on life science transactions. Tonix's CEO, Seth Lederman, highlighted Stillwell's potential to add strategic value to the company. Tonix focuses on developing therapeutics for various conditions, including fibromyalgia and Long COVID, with several clinical trials underway. Investors await interim data from ongoing studies in 2023.
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) recently participated in a virtual event co-hosted by BIO and Solve M.E., discussing Long COVID and its relation to chronic pain syndromes like fibromyalgia and CFS/ME. CEO Seth Lederman highlighted the overlap between Long COVID symptoms and chronic pain conditions. Tonix is advancing its Phase 2 PREVAIL study of TNX-102 SL, targeting Long COVID patients with symptoms similar to fibromyalgia. This randomized study is expected to enroll around 470 participants, with interim analysis anticipated after 50% enrollment.
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) announced that CEO Seth Lederman will present at a virtual event co-hosted by BIO and Solve M.E. on February 21, 2023, focusing on Long COVID and emerging therapeutic approaches. The session will explore recent research related to Long COVID, a condition affecting many post-COVID-19 patients, and will include participation from various stakeholders, including researchers and policymakers. Registration for the event is publicly available, and the presentation will be accessible on Tonix's website afterward. The company is also advancing clinical studies for its lead candidate TNX-102 SL to manage Long COVID.