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 (TNXP) is a clinical-stage biopharmaceutical company developing innovative therapeutics for central nervous system disorders, immunology, and infectious diseases. This page provides timely updates on TNXP's clinical trials, regulatory milestones, and strategic initiatives.
Key resources for investors include press releases covering product development progress, partnership announcements, and financial reports. Our curated news collection helps track TNXP's pipeline candidates like TNX-102 SL for fibromyalgia and Tonmya™ for PTSD management.
Stay informed about developments in migraine therapeutics, rare disease research, and vaccine programs. Content categories include FDA communications, clinical trial results, intellectual property updates, and market expansion activities.
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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.
Tonix Pharmaceuticals (Nasdaq: TNXP) announced its inclusion in the broad-market Russell 3000® Index and small-cap Russell 2000® Index, effective June 30, 2025. This addition comes as part of the 2025 Russell indexes reconstitution, which captures the 4,000 largest US stocks based on market capitalization rankings as of April 30.
The company is currently awaiting an FDA decision on TNX-102 SL for fibromyalgia management, with a PDUFA date of August 15, 2025. The FDA has granted Fast Track designation for this candidate. Additionally, Tonix has secured a contract worth up to $34 million over five years with the U.S. DoD's Defense Threat Reduction Agency for TNX-4200, a broad-spectrum antiviral agent.
Tonix's commercial subsidiary, Tonix Medicines, currently markets Zembrace® SymTouch® and Tosymra® for acute migraine treatment. The company's development portfolio includes various candidates targeting CNS disorders, immunology, and infectious diseases, with a state-of-the-art infectious disease research facility in Frederick, Md.