On May 12, 2025, Tonix Pharmaceuticals Holding Corp. (TNXP) announced financial results for the first quarter of 2025 and provided a business update. The company is continuing pre-commercialization activities in preparation for the PDUFA date of August 15, 2025 for TNX-102 SL for the management of fibromyalgia. If approved, TNX-102 SL would be the first new treatment option for fibromyalgia in more than 15 years. The FDA has already announced that no Advisory Committee meeting will be necessary to discuss the TNX-102 SL New Drug Application (NDA) and we believe the two positive Phase 3 trials showing a statistically significant reduction in the chronic, widespread pain associated with fibromyalgia support its eventual approval.
