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.
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