04:25 PM EDT, 08/15/2025 (MT Newswires) -- Tonix Pharmaceuticals ( TNXP ) said Friday that US Food and Drug Administration approved Tonmya for the treatment for fibromyalgia, a chronic pain condition, in adults.

The move makes Tonmya the first new FDA-approved therapy for treatment of fibromyalgia in over 15 years, the company said.

The regulatory nod came from the efficacy based on two Phase 3 trials conducted on about 1,000 patients. The trials showed notable reduction in pain when compared with placebo.

The company said it expects commercial availability of Tonmya in the fourth quarter.

Shares, which were halted ahead of the FDA's approval, were up over 13% in after hours trading.