Tonix Pharmaceuticals (NASDAQ:TNXP) is a clinical-stage biopharmaceutical company focused on discovering, developing, and commercializing novel therapies for central nervous system (CNS) disorders, immunological conditions, and rare diseases. Founded in 2007 and headquartered in New York, Tonix applies its translational research expertise to address unmet medical needs by advancing a diverse pipeline of product candidates through preclinical and clinical development stages. The company’s strategy centers on leveraging both pharmaceutical and vaccine platforms to deliver differentiated treatments across multiple therapeutic areas.
Tonix’s lead asset, TNX-102 SL, is a proprietary sublingual formulation of cyclobenzaprine designed to treat fibromyalgia and post-traumatic stress disorder (PTSD). The company has completed Phase 3 efficacy studies in fibromyalgia and is conducting trials in PTSD, aiming to offer patients an alternative to existing therapies with a convenient sublingual delivery system. In addition to its CNS portfolio, Tonix is developing TNX-801, a live vaccinia virus vaccine candidate for smallpox and monkeypox preparedness, and TNX-3500, an engineered oncolytic virus for potential cancer immunotherapy. These vaccine and immunotherapy programs stem from Tonix’s broader commitment to biodefense and immuno-oncology research.
Operating primarily in the United States, Tonix collaborates with governmental agencies, contract research organizations, and academic institutions to support its development activities and regulatory interactions. The company maintains facilities in New York and Massachusetts, where its multidisciplinary teams conduct translational research, process development, and clinical operations. Tonix’s leadership is helmed by CEO Seth Lederman, a neuroscientist and entrepreneur who cofounded the company and has overseen its expansion from a single-asset entity into a multifaceted biotech organization.
Looking ahead, Tonix aims to advance its pipeline through pivotal trials and regulatory submissions, while exploring strategic partnerships to accelerate commercialization and broaden geographic reach. By integrating novel formulation technologies and viral vector platforms, the company seeks to create value for patients and shareholders through targeted innovation in CNS, immunology, and rare disease therapeutics.
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