Tonix Pharma Stock Climbs As FDA Waives Advisory Meeting For TNX-102 SL For Fibromyalgia

(RTTNews) - 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. Fibromyalgia afflicts more than 10 million adults in the U.S., the majority of whom are women.

TNX-102 SL (cyclobenzaprine HCl sublingual tablets) is a centrally acting, non-opioid investigational drug, designed for chronic use.

The fully-integrated biopharmaceutical company noted that it is on track for August 15 FDA PDUFA (Prescription Drug User Fee act) goal date.

The FDA was to discuss the Company's New Drug Application or NDA for TNX-102 SL, which was submitted based on two statistically significant Phase 3 studies for the management of fibromyalgia. The agency in 2024 had granted Fast Track designation to TNX-102 SL for fibromyalgia.

Seth Lederman, M.D., President, and Chief Executive Officer of Tonix Pharma, said, "We believe that TNX-102 SL has the potential to be the first member of a new class of medicines for the management of fibromyalgia, a debilitating condition affecting over 10 million adults in the U.S. We believe we are well positioned to launch TNX-102 SL for the management of fibromyalgia in the fourth quarter of 2025 if approved by the FDA."

TNX-102 SL is also being developed to treat acute stress reaction and acute stress disorder under a Physician-Initiated IND at the University of North Carolina in the OASIS study funded by the U.S. Department of Defense or DoD.

On the Nasdaq, Tonix shares are currently trading at $31.05, up 34.8 percent.

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