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 (Nasdaq: TNXP) has announced the in-licensing of worldwide rights to TNX-4800, a long-acting human monoclonal antibody designed for seasonal prevention of Lyme disease. The antibody targets the outer surface protein A (OspA) of Borrelia burgdorferi, the bacteria causing Lyme disease.
The treatment, developed by UMass Chan Medical School researchers, requires just one subcutaneous dose in Spring to provide protection through Fall. TNX-4800 has shown positive Phase 1 results with safety, tolerability, and linear pharmacokinetic relationships. The potential market includes approximately 70 million people living in Lyme disease endemic areas in the U.S.
TNX-4800 works by blocking Borrelia maturation in infected tick midguts, offering immediate immunity without requiring the recipient's immune system to generate antibodies. The company plans to advance the treatment through additional clinical trials toward a Biologics Licensing Application (BLA).
Tonix Pharmaceuticals (NASDAQ:TNXP) presented clinical data for Tonmya™, its recently FDA-approved treatment for fibromyalgia, at PAINWEEK 2025. The drug, approved on August 15, 2025, represents the first new FDA-approved fibromyalgia treatment in over 15 years.
The presentation included results from two pivotal Phase 3 trials (RELIEF and RESILIENT) demonstrating that Tonmya significantly reduced fibromyalgia pain compared to placebo. The drug showed consistent improvements across core symptoms, including widespread pain, sleep disturbance, and fatigue, while maintaining a favorable tolerability profile.
Tonmya works by targeting nonrestorative sleep through receptor antagonism that regulates sleep architecture. The company expects commercial availability in Q4 2025.
Tonix Pharmaceuticals (Nasdaq: TNXP) announced that CEO Seth Lederman will participate in a fireside chat at the 2025 Cantor Global Healthcare Conference on September 4, 2025, at 1:35 PM ET. The event will be webcast and available for replay on the company's investor relations website.
The press release highlights Tonix's recent milestone of receiving FDA approval for Tonmya™, their first-in-class, non-opioid analgesic for fibromyalgia - the first new prescription medicine approval for this condition in over 15 years. The company's pipeline includes developments in CNS disorders, immunology, and infectious diseases, including TNX-4200, supported by a $34 million DoD contract.
Tonix Pharmaceuticals (Nasdaq: TNXP) has received FDA approval for Tonmya™, a groundbreaking treatment for fibromyalgia in adults - the first new therapy approved in over 15 years. This non-opioid, sublingual tablet is designed for once-daily bedtime use with rapid bloodstream absorption.
Two pivotal Phase 3 clinical trials involving nearly 1,000 patients demonstrated significant pain reduction compared to placebo at 14 weeks. The drug showed favorable tolerability across three Phase 3 trials with over 1,400 patients. Commercial launch is expected in Q4 2025, targeting a market of over 10 million U.S. adults affected by fibromyalgia.
Tonix Pharmaceuticals (Nasdaq: TNXP) reported Q2 2025 financial results and operational highlights, with key focus on their lead candidate TNX-102 SL for fibromyalgia, which has an FDA PDUFA date of August 15, 2025. The company reported $125.3 million in cash and cash equivalents as of June 30, 2025.
Q2 2025 financial results showed net product revenue of $2.0 million and a net loss of $28.3 million ($3.86 per share). The company's cash runway is expected to extend into Q3 2026, supported by recent equity offerings that raised $51.5 million in net proceeds.
Notable developments include the company's addition to the Russell 3000® and Russell 2000® Indexes, publication of positive Phase 3 RESILIENT trial results in Pain Medicine, and progress across their CNS and immunology pipeline, including TNX-1500 and TNX-801.
Tonix Pharmaceuticals (Nasdaq: TNXP) has launched the "Move Fibro Forward" campaign through its commercial subsidiary, Tonix Medicines, Inc. The initiative aims to raise awareness and provide support for individuals affected by fibromyalgia, a condition that has not seen new FDA-approved treatments in over 15 years.
The campaign represents Tonix's commitment to the fibromyalgia community, focusing on validating patient experiences and providing educational resources. The initiative is supported by the Fibromyalgia Association, emphasizing the importance of visibility and support for those affected by this debilitating condition.
Tonix Pharmaceuticals (Nasdaq: TNXP) presented new data on TNX-801, their mpox and smallpox vaccine candidate, at the Vaccine Congress 2025. The vaccine shows promising characteristics including up to 100,000-fold less virulence than traditional smallpox vaccines while providing robust protection. Key findings demonstrate that subcutaneous administration offers equivalent protection to traditional percutaneous delivery.
TNX-801 demonstrated strong binding and neutralizing antibody responses across multiple animal species, with macaques showing 100% survival against lethal mpox challenge without lesions. The vaccine provided protection lasting over 14 months in rabbit models. The company plans to advance TNX-801 to clinical trials using subcutaneous delivery, positioning it as a potential single-dose solution for mpox and smallpox prevention.
Tonix Pharmaceuticals (NASDAQ:TNXP) has published results from its Phase 3 RESILIENT trial of TNX-102 SL for fibromyalgia in Pain Medicine journal. The trial demonstrated statistically significant improvement in reducing fibromyalgia pain compared to placebo, with a 1.8-point reduction versus 1.2-point for placebo on the daily pain scale.
The study, involving 457 adults across 33 U.S. sites, showed significant improvements across all six key secondary endpoints. TNX-102 SL was generally well-tolerated, with mild side effects. The FDA's PDUFA decision date is set for August 15, 2025, and if approved, it would be the first new fibromyalgia treatment in over 15 years.
Tonix Pharmaceuticals (Nasdaq: TNXP) announced that Dr. Sina Bavari will present new data on TNX-801, their mpox and smallpox vaccine candidate, at the Vaccine Congress 2025 in Vienna, Austria. TNX-801 is a minimally replicative, attenuated live virus vaccine that has shown promising preclinical results, demonstrating protection against mpox and other orthopoxviruses after a single dose.
The presentation, scheduled for July 10th at 11:20am GMT+2, will highlight TNX-801's safety, immunogenicity, and efficacy findings. The vaccine has demonstrated durable protection and good tolerability in immunocompromised animals, with no evidence of spreading to blood or tissues even at high doses. TNX-801 also serves as a platform that can deliver multiple protective antigens against diverse viral pathogens.
Additionally, Tonix has a $34 million contract with the U.S. DoD's Defense Threat Reduction Agency for TNX-4200, a broad-spectrum antiviral agent.
Tonix Pharmaceuticals (NASDAQ:TNXP) has published positive preclinical data in Cancer Cell journal regarding mTNX-1700, their experimental cancer treatment. The study demonstrated that combining mTNX-1700 with anti-PD1 antibody therapy significantly improved survival rates and reduced metastases in gastric cancer animal models.
The research showed that mTNX-1700, a fusion protein combining murine trefoil factor-2 (mTFF2) and murine serum albumin (MSA), effectively reduces immunosuppressive neutrophils and enhances anti-tumor immune responses. The human version, TNX-1700, is currently in preclinical development for gastric and colorectal cancers.
Key findings revealed that the combination therapy successfully shrank primary tumors, reduced liver and lung metastases, and activated cancer-killing CD8+ T cells while limiting neutrophil-mediated immune evasion.
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