Tonix Pharma’s IND Clearance Boosts MDD Treatment Efforts

Tonix Pharma ( (TNXP) ) has shared an update.

On November 24, 2025, Tonix Pharmaceuticals announced that the FDA cleared their IND application for TNX-102 SL, a sublingual tablet designed to treat major depressive disorder in adults. The clearance allows the company to proceed with the Phase 2 HORIZON study, a 6-week trial involving 360 patients across 30 U.S. sites, comparing TNX-102 SL to a placebo. This development marks a significant step in Tonix’s clinical development efforts and could impact their market positioning by addressing unmet needs in MDD treatment.

The most recent analyst rating on (TNXP) stock is a Sell with a $17.00 price target. To see the full list of analyst forecasts on Tonix Pharma stock, see the TNXP Stock Forecast page.

Spark’s Take on TNXP Stock

According to Spark, TipRanks’ AI Analyst, TNXP is a Underperform.

Tonix Pharma’s overall stock score is primarily impacted by its financial performance and valuation challenges. The company faces significant profitability and cash flow issues, which are reflected in its negative P/E ratio. Technical analysis indicates a bearish trend, with the stock trading below key moving averages and approaching oversold conditions. These factors collectively contribute to a low overall stock score.

To see Spark’s full report on TNXP stock, click here.

More about Tonix Pharma

Tonix Pharmaceuticals Holding Corp. operates in the pharmaceutical industry, focusing on developing innovative therapies for central nervous system disorders. The company’s primary product candidate, TNX-102 SL, is aimed at treating major depressive disorder (MDD) in adults, with a market focus on addressing sleep disturbances associated with MDD.

Average Trading Volume: 959,062

Technical Sentiment Signal: Sell

Current Market Cap: $189.6M

For an in-depth examination of TNXP stock, go to TipRanks’ Overview page.