Tonix completes positive Pre-IND meeting with FDA for TNX-102 SL in MDD; IND filing Q4 2025

Tonix Pharmaceuticals Holding Corp.

FDA found proposed long-term safety data collection plan generally reasonable, potentially streamlining development.
Company plans to pursue sNDA to expand TNX-102 SL indication to include MDD.
IND filing for TNX-102 SL in MDD planned for Q4 2025; Phase 2 trial expected shortly after.
TNX-102 SL (sublingual cyclobenzaprine HCl) is already FDA-approved for fibromyalgia as Tonmya.
Decision based on exploratory findings that improving sleep quality may positively impact depressive symptoms.

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