Tonix Pharmaceuticals (TNXP) said Wednesday it submitted a new drug application to the US Food and Drug Administration for TNX-102 SL, an investigational drug in development to treat fibromyalgia.
TNX-102 SL showed a "statistically significant reduction" in pain linked with fibromyalgia in two phase 3 studies and was generally well tolerated, the company said.
The investigational drug was given fast track designation for fibromyalgia by the FDA in July, Tonix said.
Tonix said that, if the regulator accepts the new drug application for review, it expects a 2025 date for an approval decision, based on the Prescription Drug User Fee Act.
The company's shares were rising past 3% in recent trading.
Price: 0.15, Change: +0.01, Percent Change: +3.55
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