TNXP - Tonix stock rises on FDA nod to start trial of TNX-601 for depression

• The U.S. Food and Drug Administration (FDA) cleared Tonix Pharmaceuticals' ( NASDAQ: TNXP ) application seeking to start a phase 2 of TNX-601 ER to treat major depressive disorder (MDD).
• TNX-601 ER (tianeptine hemioxalate extended-release tablets) is a once-daily formulation of tianeptine — a new molecular entity in the U.S. which is being developed under the 505(b)(1) pathway, the company said in an Oct. 3 press release.
• Tonix added that tianeptine sodium (amorphous) immediate release (IR) tablets have been available in Europe and many countries in Asia and Latin America to treat depression, since it was first marketed in France in 1989.
• "We expect that our new once-daily formulation will maintain these properties while also providing convenience and adherence advantages over the three-times-a-day dosing of these IR tianeptine sodium products," said Tonix CEO Seth Lederman.
• The company expects to begin the phase 2 trial, for which the  in MDD in the investigational new drug application was filed, in Q1 2023.
• TNXP +3.01% to $0.55 premarket Oct. 3

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