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Tonix Pharma Completes FDA Meeting for TNX-102 SL

Story Highlights
  • Tonix Pharmaceuticals completed a Type B Pre-IND meeting with the FDA for TNX-102 SL.
  • FDA feedback may streamline TNX-102 SL development, with Phase 2 trials expected soon.
  • Looking for the best stocks to buy? Follow the recommendations of top-performing analysts.
Tonix Pharma Completes FDA Meeting for TNX-102 SL

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

On September 18, 2025, Tonix Pharmaceuticals announced the completion of a Type B Pre-IND meeting with the FDA for its TNX-102 SL product candidate aimed at treating major depressive disorder. The FDA’s feedback was positive, suggesting that the proposed long-term safety data collection plan is reasonable, which may streamline the development path. Tonix plans to file an Investigational New Drug application in the fourth quarter of 2025 and expects to enter Phase 2 clinical trials soon after, potentially expanding the therapeutic indications of TNX-102 SL.

The most recent analyst rating on (TNXP) stock is a Hold with a $41.00 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 Neutral.

Tonix Pharma’s overall score is driven by strong corporate events, particularly the FDA approval of Tonmya, which significantly boosts its market potential. However, challenges in profitability and valuation weigh down the score. Mixed technical indicators suggest cautious optimism.

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 the development of innovative therapeutics. The company is primarily engaged in creating treatments for central nervous system disorders, with a market focus on unmet medical needs.

Average Trading Volume: 1,456,977

Technical Sentiment Signal: Sell

Current Market Cap: $242.9M

See more data about TNXP stock on TipRanks’ Stock Analysis page.

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