Why Is Dementia Focused BioXcel Therapeutics Stock Trading Lower Today?

BioXcel Therapeutics Inc BTAI announced alignment with the FDA's recommendation for a Phase 3 trial in the TRANQUILITY program of BXCL501 for acute treatment of agitation associated with Alzheimer's dementia.

The company aligned with the FDA's recommendation to conduct an additional Phase 3 trial of BXCL501 to evaluate safety and collect additional efficacy data in at-home setting.

• The planned study is expected to enroll approximately 100 patients aged 65 years and older with mild, moderate, or severe dementia who will self-administer 60 mcg of BXCL501 or a placebo whenever agitation episodes occur over four weeks.
• TRANQUILITY III trial is no longer required for potential supplemental marketing application submission. The company plans to explore a potential separate clinical development program for chronic agitation.

The company completed the FDA meeting, with meeting minutes expected by the first half of December 2023 for at-home use of BXCL501 for agitation associated with bipolar disorders or schizophrenia.

• Based on FDA feedback, BioXcel plans to conduct a Phase 3 trial with 120 mcg (Igalmi approved dose) to evaluate safety in at-home setting.

For Q3, the company reported Igalmi sales of approximately $341,000 compared to $137,000 a year ago. Cash and cash equivalents totaled $90.0 million. 

The company entered into a binding term sheet to restructure key financial terms in its agreements with Oaktree Capital Management and Qatar Investment Authority.

BioXcel estimates its current cash and cash equivalents will fund its operations through mid-2024. 

Price Action: BTAI shares are down 24.10% at $4.18 on the last check Tuesday.