On March 11, 2024, Tonix Pharmaceuticals Holding Corp. announced positive additional efficacy data from the Phase 3 RESILIENT study of its product candidate Tonmya, for the management of fibromyalgia, at the 6th International Congress on Controversies in Fibromyalgia. The study met its primary endpoint of daily pain reduction and achieved statistically significant improvement on all six key pre-specified secondary endpoints with effect sizes ranging from 0.3 to 0.5. Notably, the treatment resulted in an improvement in cognitive dysfunction, commonly referred to as 'brain fog', as measured by the Fibromyalgia Impact Questionnaire-Revised (FIQ-R) memory item. The company plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in the second half of 2024, following a pre-NDA meeting...Show More

On March 11, 2024, Tonix Pharmaceuticals Holding Corp. announced positive additional efficacy data from the Phase 3 RESILIENT study of its product candidate Tonmya, for the management of fibromyalgia, at the 6th International Congress on Controversies in Fibromyalgia. The study met its primary endpoint of daily pain reduction and achieved statistically significant improvement on all six key pre-specified secondary endpoints with effect sizes ranging from 0.3 to 0.5. Notably, the treatment resulted in an improvement in cognitive dysfunction, commonly referred to as 'brain fog', as measured by the Fibromyalgia Impact Questionnaire-Revised (FIQ-R) memory item. The company plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in the second half of 2024, following a pre-NDA meeting with the FDA scheduled for the second quarter of 2024. Tonix's CEO, Seth Lederman, highlighted the broad-spectrum activity of Tonmya, suggesting it treats fibromyalgia at a syndromal level. The RESILIENT study, which enrolled 457 participants across 33 sites in the U.S., demonstrated that Tonmya was well-tolerated with the most common adverse events being transient and self-limited local administration site reactions.