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BioXcel Therapeutics Receives Positive FDA Feedback

Story Highlights
  • BioXcel Therapeutics focuses on innovative medicines for agitation in bipolar and schizophrenia.
  • Positive FDA feedback supports BioXcel’s sNDA submission for BXCL501 in early 2026.
  • Looking for the best stocks to buy? Follow the recommendations of top-performing analysts.
BioXcel Therapeutics Receives Positive FDA Feedback

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The latest announcement is out from Bioxcel Therapeutics ( (BTAI) ).

On August 18, 2025, BioXcel Therapeutics announced it received positive feedback from the FDA regarding its planned supplemental new drug application (sNDA) for BXCL501, intended for treating agitation in bipolar disorders and schizophrenia in outpatient settings. This feedback suggests that the company’s sNDA submission, scheduled for the first quarter of 2026, will likely meet the necessary regulatory requirements, eliminating the need for a previously scheduled meeting with the FDA.

The most recent analyst rating on (BTAI) stock is a Buy with a $112.00 price target. To see the full list of analyst forecasts on Bioxcel Therapeutics stock, see the BTAI Stock Forecast page.

Spark’s Take on BTAI Stock

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

Bioxcel Therapeutics’ stock is rated at the lowest end of the scale due to substantial financial instability, including ongoing losses, high debt, and negative cash flows. Short-term technical indicators and valuation metrics further highlight the current challenges. The company needs to address these financial and operational issues to improve its stock performance.

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

More about Bioxcel Therapeutics

BioXcel Therapeutics, Inc. operates in the pharmaceutical industry, focusing on the development of innovative medicines. Its primary product, BXCL501, is targeted at treating agitation associated with bipolar disorders and schizophrenia, particularly in outpatient settings.

Average Trading Volume: 7,585,290

Technical Sentiment Signal: Hold

Current Market Cap: $79.77M

For a thorough assessment of BTAI stock, go to TipRanks’ Stock Analysis page.

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