BioXcel Therapeutics Inc. has announced positive results from a correlation study related to exploratory efficacy outcomes from the SERENITY At Home trial. The study evaluated the correlation between the Positive and Negative Syndrome Scale - Excited Component (PEC), administered by a clinician, and the modified Clinical Global Impression-Severity (mCGI-S) scale, which can be rated by patients or caregivers. The prospective, open-label, in-clinic trial included 33 patients and demonstrated a strong correlation between clinician and patient/caregiver assessments, with correlation coefficients of ρ=0.89 (patients) and ρ=0.88 (informants), both with p<0.0001. No serious adverse events were reported and the safety profile was consistent with the current IGALMI® label. The results, along with data from the SERENITY At Home trial, will be included in a supplemental New Drug Application (sNDA) submission planned for the first quarter of 2026.
Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. BioXcel Therapeutics Inc. published the original content used to generate this news brief via EDGAR, the Electronic Data Gathering, Analysis, and Retrieval system operated by the U.S. Securities and Exchange Commission (Ref. ID: 0001104659-25-098992), on October 14, 2025, and is solely responsible for the information contained therein.
Comments