After a major regulatory update, Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) saw a sharp increase in the value of its shares. TNXP shares were up 35.02% to $31.10 as of the most recent market check. The spike comes after the business revealed that TNX-102 SL, its experimental fibromyalgia therapy, is being reviewed by regulators.
The FDA Removes the Need for an Advisory Committee Assessment
Tonix Pharmaceuticals stated that the FDA has decided not to convene an Advisory Committee meeting to review the company’s New Drug Application (NDA) for TNX-102 SL, a sublingual form of cyclobenzaprine hydrochloride. If approved, TNX-102 SL would be the first new pharmacological treatment for fibromyalgia in 15 years, providing millions of patients with the ailment with a new therapeutic option.
Understanding Fibromyalgia’s Effects
Central sensitization, in which the central nervous system amplifies pain and sensory impulses, is a characteristic of fibromyalgia, a widespread chronic pain disorder. Neuroimaging studies have revealed significant functional abnormalities in the insula and anterior cingulate cortex of the brain.
The illness affects more than 10 million persons, with a greater frequency among women. Fatigue, non-restorative sleep, chronic, pervasive discomfort, and cognitive impairment—often referred to as “brain fog”—are typical symptoms. Furthermore, psychological issues including anxiety, sadness, headaches, and gastrointestinal distress are frequently linked to fibromyalgia.
Route to Possible Market Introduction
The FDA’s trust in the current clinical evidence supporting TNX-102 SL is indicated by the lack of an Advisory Committee requirement. TNXP anticipates the medication to possibly go on sale in Q4 2025, pending regulatory approval.
TNX-102 SL would introduce a novel class of medications specifically made to treat fibromyalgia if it were authorized. In 2024, the company already received a Fast Track designation for TNX-102 SL. For drugs that address critical medical needs, this FDA initiative speeds up the review process.
This regulatory milestone further demonstrates Tonix Pharmaceuticals’ commitment to addressing unmet medical needs in chronic pain management and positioned the firm for a major advancement in the therapeutic landscape for fibromyalgia.