08:43 AM EDT, 03/24/2025 (MT Newswires) -- Tonix Pharmaceuticals ( TNXP ) said Monday that the US Food and Drug Administration will not require an advisory committee meeting regarding its new drug application for TNX-102 SL, a product candidate to treat fibromyalgia.

The biopharmaceutical company said the drug candidate is on track to meet the FDA's prescription drug user fee act goal of Aug. 15.

Shares of the company were up 16% in recent Monday premarket activity.