Tonix Pharmaceuticals Announces Publication of Phase 3 RESILIENT Trial Data for TNX-102 SL

Tonix Pharmaceuticals Holding Corp.

Full results from confirmatory Phase 3 RESILIENT trial of TNX-102 SL published online in Pain Medicine on July 9, 2025.
TNX-102 SL achieved statistically significant improvement in primary endpoint of reducing fibromyalgia pain vs placebo (LS mean reduction 1.8 vs 1.2 points).
Statistically significant improvements observed across all six prespecified key secondary endpoints.
FDA PDUFA target date for TNX-102 SL is August 15, 2025; if approved, would be first new fibromyalgia drug in over 15 years.
TNX-102 SL was generally well tolerated; most common AEs were mild oral tingling/numbness and aftertaste, no drug-related serious AEs.

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