Tonix presents positive Phase 3 TNX-102 SL data at EULAR; PDUFA Aug 15, 2025

Tonix Pharmaceuticals Holding Corp.

TNX-102 SL (sublingual cyclobenzaprine) showed statistically significant pain reduction in Phase 3 RESILIENT study at 14 weeks.
FDA PDUFA goal date for TNX-102 SL is August 15, 2025; if approved, would be first new fibromyalgia drug in >15 years.
Novel mechanism targets non-restorative sleep by acting on four post-synaptic receptors regulating sleep.
Non-opioid analgesic designed for transmucosal delivery to bypass first-pass metabolism and reduce norcyclobenzaprine accumulation.
Data presented at Annual European Congress of Rheumatology (EULAR) 2025 in Barcelona, June 11-14.

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