09:00 AM EDT, 09/18/2025 (MT Newswires) -- Tonix Pharmaceuticals ( TNXP ) announced Thursday it has completed a Type B pre-investigational new drug meeting with the US Food and Drug Administration regarding the development of TNX-102 SL for major depressive disorder.

The company said it received positive and constructive feedback from the FDA and now plans to submit a supplemental new drug application to expand the use of TNX-102 SL, currently approved for fibromyalgia, to include major depressive disorder.

Tonix said the FDA found its proposed long-term safety data plan generally reasonable, which could help streamline future development.

The company added that it plans to file an investigational new drug application in Q4, with Phase 2 trials expected to begin shortly thereafter.

The decision is based on exploratory data from a Phase 3 fibromyalgia study, where TNX-102 SL showed potential to improve depressive symptoms, the drug developer said.