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Tonix Pharmaceuticals Gets FDA Fast Track Label For Tonmya; Shares Rise
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Tonix Pharmaceuticals Gets FDA Fast Track Label For Tonmya; Shares Rise
Jul 25, 2024 8:28 AM

11:06 AM EDT, 07/25/2024 (MT Newswires) -- Tonix Pharmaceuticals ( TNXP ) said Thursday that the US Food and Drug Administration has granted its fast track designation to Tonmya for the management of fibromyalgia, a common chronic pain condition affecting mostly women.

The company said it remains on track to submit its new drug application for Tonmya to the FDA in H2.

The fast track process allows companies to have more meetings with the FDA during clinical trials, the company said, adding that it intends to seek priority review status, which could accelerate the FDA's review of its new drug application.

Shares of Tonix Pharmaceuticals ( TNXP ) were up more than 6% in recent trading.

Price: 0.56, Change: +0.03, Percent Change: +6.30

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