NASDAQ — Healthcare: Manufacturing, Biotechnology: Pharmaceutical Preparations
www.tonixpharma.comTonix Pharmaceuticals Holding Corp. has updated guidance for the timing of topline data from its Phase 2 study of TNX-1300, a drug candidate aimed at treating cocaine intoxication, which is now expected in Q3 2025. This information was released as part of a current report on January 8, 2025, outlining key developments and expectations surrounding the company's clinical trials. Investors should note that TNX-1300 is part of Tonix's broader strategy to develop innovative therapies addressing significant unmet medical needs, which may impact its market performance and investor interest in future results.
Guidance UpdateThe U.S. Food and Drug Administration (FDA) is expected to make a decision on the New Drug Application (NDA) for Tonix Pharmaceuticals' TNX-102 SL in August 2025, pending the acceptance of the NDA for standard review in December 2024. TNX-102 SL is a product candidate designed for the management of fibromyalgia. The company has recently expanded its leadership team to support the upcoming launch of TNX-102 SL and has updated the timeline for its clinical trial activities. The decision may have significant implications for Tonix Pharmaceuticals' market position in the treatment of fibromyalgia and related conditions.
FDA DecisionOn December 23, 2024, Tonix Pharmaceuticals Holding Corp. announced that the U.S. Food and Drug Administration (FDA) assigned a Prescription Drug User Fee Act (PDUFA) goal date of August 15, 2025, for a decision on the marketing approval of TNX-102 SL (cyclobenzaprine HCl sublingual tablets) for the management of fibromyalgia. This product candidate aims to provide symptom relief for patients with fibromyalgia, which is characterized by chronic pain, fatigue, and other debilitating symptoms. The outcome of the FDA's decision could significantly impact Tonix Pharmaceuticals' market position and financial performance if approved.
Regulatory Approval