08:59 AM EST, 12/23/2024 (MT Newswires) -- Tonix Pharmaceuticals ( TNXP ) said Monday that the US Food and Drug Administration had set a target action date of Aug. 15, 2025, for TNX-102 SL sublingual tablets to potentially treat fibromyalgia.

The company said its new drug application for TNX-102 SL, or cyclobenzaprine HCl, is supported by the results of two phase 3 trials that showed the treatment candidate significantly reduced pain compared to placebo and was well-tolerated.

Tonix's shares were falling more than 18% in recent premarket activity.