On December 23, 2024, Tonix Pharmaceuticals Holding Corp. (TNXP) announced that the FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of August 15, 2025 for a decision on the NDA for TNX-102 SL for fibromyalgia. TNX-102 SL has the potential to become the first new treatment for fibromyalgia in more than 15 years. The company also recently announced that it had approximately $98.9 million in cash and cash equivalents as of Dec. 31, 2024, raised approximately $30 million in January 2025, and has no long-term debt following the payoff of its $11.0 million term loan. Lastly, Tonix announced positive Phase 1 results for TNX-1500, with the company planning to meet with the FDA in preparation for a Phase 2 clinical trial for the prevention of kidney transplant rejection.
