BioXcel Therapeutics Reports Positive Phase 3 Trial Results

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

On September 10, 2025, BioXcel Therapeutics announced positive results from its SERENITY At-Home Pivotal Phase 3 trial, which evaluated the safety and efficacy of BXCL501 for treating agitation in bipolar and schizophrenia patients at home. The trial demonstrated significant reductions in agitation symptoms with BXCL501 compared to placebo, reinforcing its potential for at-home use. This development could address a significant unmet need in the market, as there are currently no FDA-approved at-home treatments for such conditions, and the total addressable market is larger than previously estimated.

The most recent analyst rating on (BTAI) stock is a Buy with a $18.00 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 therapies for neuropsychiatric and rare diseases. Their primary product, BXCL501, is aimed at treating acute agitation associated with bipolar disorders and schizophrenia, with a market focus on both institutional and potential at-home settings.

Average Trading Volume: 9,577,631

Technical Sentiment Signal: Sell

Current Market Cap: $61.58M

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