regulatory
confidence high
sentiment positive
materiality 0.75
BioXcel Therapeutics reports strong correlation between clinician & caregiver agitation scales; sNDA planned Q1 2026
BioXcel Therapeutics, Inc.
- Correlation study (N=33) shows ρ=0.89 (patient) and ρ=0.88 (informant) between PEC and mCGI-S scales, p<0.0001.
- No serious adverse events; safety profile consistent with IGALMI label.
- Results to be included in sNDA submission for BXCL501 planned for Q1 2026.
- mCGI-S scale developed with FDA for at-home efficacy assessment of acute agitation.