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BioXcel Therapeutics Updates sNDA Timeline for IGALMI®

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BioXcel Therapeutics Updates sNDA Timeline for IGALMI®

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Bioxcel Therapeutics ( (BTAI) ) has issued an update.

On October 30, 2025, BioXcel Therapeutics announced an update on the timeline for submitting a Supplemental New Drug Application (sNDA) for IGALMI® to expand its label for at-home use. Following the completion of the SERENITY At-Home Pivotal Phase 3 Safety Trial and a supporting correlation study in 2025, the company anticipates submitting the sNDA in early 2026, potentially impacting its market positioning and offering new treatment options for patients.

The most recent analyst rating on (BTAI) stock is a Buy with a $10.00 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 biopharmaceutical industry, focusing on the development of innovative medicines for the treatment of neuropsychiatric and rare diseases. Its primary product, IGALMI®, is FDA-approved for the acute treatment of agitation related to bipolar I or II disorder and schizophrenia in medically supervised settings.

Average Trading Volume: 9,865,873

Technical Sentiment Signal: Sell

Current Market Cap: $40.67M

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

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