08:33 AM EDT, 07/08/2024 (MT Newswires) -- Tonix Pharmaceuticals ( TNXP ) said Monday that it has received positive feedback from a final pre-New Drug Application meeting with the US Food and Drug Administration regarding its drug, Tonmya, for fibromyalgia.

The company said the FDA agreed that the current data is adequate for an NDA submission, which Tonix plans to file in the second half of 2024, aiming for potential approval in the second half of 2025.

Shares of the company were up 5% in recent Monday premarket activity.

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