Tonix shares jump 10.18% intraday after FDA approves Tonmya, first new fibromyalgia therapy in over 15 years.

Tonix Pharmaceuticals Holding Corp. (TNXP) surged 10.18% intraday following the U.S. Food and Drug Administration’s clearance of its IND application for TNX-102 SL, enabling a Phase 2 trial for major depressive disorder. The FDA approval marked a pivotal step in advancing the drug’s development, with the trial set to enroll 360 patients across 30 U.S. sites. Concurrently, the company’s recent FDA approval of Tonmya™, the first new fibromyalgia treatment in over 15 years, further reinforced investor confidence. A. G. P. analyst James Molloy’s reaffirmed “buy” rating with a $65 price target also contributed to the upward momentum. These developments—regulatory progress, a novel therapeutic offering, and analyst support—collectively drove the intraday rally, highlighting Tonix’s advancing pipeline and unmet medical need in mental health and chronic pain markets.