India, March 24 -- Shares of Tonix Pharmaceuticals Holding Corp. (TNXP) are gaining around 35 percent in the early morning trading on the Nasdaq after the company announced Monday that the U.S. Food and Drug Administration will not require an Advisory Committee meeting as part of the regulatory review process for TNX-102 SL for the management of fibromyalgia.
The commercial planning for TNX-102 SL is underway for launch in the fourth quarter of 2025. If approved, TNX-102 SL would become the first new drug for treating fibromyalgia in more than 15 years.
Fibromyalgia, a common chronic pain disorder, is understood to result from amplified sensory and pain signaling within the central nervous system, called central sensitization. Fibromyalgi...