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BioXcel Submits IGALMI® Application for FDA Review

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BioXcel Submits IGALMI® Application for FDA Review

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Bioxcel Therapeutics ( (BTAI) ) has shared an announcement.

On July 21, 2025, BioXcel Therapeutics announced the submission of a pre-supplemental New Drug Application meeting package to the FDA for IGALMI®, aiming to expand its label for outpatient use in treating agitation linked to bipolar disorders and schizophrenia. The meeting, set for August 20, 2025, seeks to align with the FDA on the submission details and reconfirm previous understandings, potentially impacting the company’s market positioning by broadening the drug’s application scope.

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 operates in the biopharmaceutical industry, focusing on developing innovative medicines for neuropsychiatric disorders. Its primary product, IGALMI®, targets the treatment of agitation associated with bipolar disorders and schizophrenia.

Average Trading Volume: 308,537

Technical Sentiment Signal: Sell

Current Market Cap: $11.57M

Learn more about BTAI stock on TipRanks’ Stock Analysis page.

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