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BioXcel seeks FDA approval for at-home IGALMI use

Story Highlights
  • BioXcel focuses on neuropsychiatric drugs, led by IGALMI.
  • In January 2026 it sought FDA approval to expand IGALMI for at-home agitation treatment, targeting an unmet market need.
  • Looking for the best stocks to buy? Follow the recommendations of top-performing analysts.
BioXcel seeks FDA approval for at-home IGALMI use

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Bioxcel Therapeutics ( (BTAI) ) just unveiled an announcement.

On January 20, 2026, BioXcel Therapeutics announced that it had submitted a supplemental New Drug Application on January 14, 2026 to the U.S. Food and Drug Administration seeking approval for IGALMI’s use in the at-home setting for the acute treatment of agitation associated with bipolar disorders or schizophrenia. The proposed label expansion would extend IGALMI beyond supervised healthcare settings to a broader at-home patient population, addressing a segment where there are currently no FDA‑approved treatment options and potentially strengthening the company’s positioning in the neuropsychiatric agitation market.

The most recent analyst rating on (BTAI) stock is a Hold with a $2.00 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 Neutral.

The score is held down primarily by weak financial performance (minimal revenue, large losses, heavy cash burn) and elevated balance sheet risk (negative equity and high debt relative to assets). Technicals show only modest near-term improvement within a broader downtrend, while valuation is hard to support due to negative earnings and no dividend. Positive clinical and regulatory-related corporate updates provide some offsetting upside.

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 treatments for neuropsychiatric conditions. Its lead product, IGALMI, is an orally dissolving sublingual film approved in April 2022 for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults, administered under the supervision of a healthcare provider.

Average Trading Volume: 628,821

Technical Sentiment Signal: Sell

Current Market Cap: $40.24M

See more insights into BTAI stock on TipRanks’ Stock Analysis page.

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