Tonix Pharmaceuticals Holding Corp. Stock News

Tonix received FDA's Day 74 Letter granting TNX-102 SL a Prescription Drug User Fee Act (PDUFA) goal date of August 15, 2025

Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) announced that the US Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for TNX-102 SL, a non-opioid, centrally acting analgesic designed for fibromyalgia management.

FDA is expected to assign a Prescription Drug User Fee Act (PDUFA) target action date and announce whether Priority Review has been granted in the Day 74 Letter

Submitted New Drug Application (NDA) to FDA for TNX-102 SL for fibromyalgia based on two statistically significant Phase 3 studies

This post was written and published as a collaboration between the in-house editorial team at Benzinga and Tonix Pharmaceuticals Holding Corp. with financial support from Tonix. The two organizations work to ensure that any and all information contained within is true and accurate as of the date hereof to the best of their knowledge and research.

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