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BioXcel Therapeutics, Inc. (Nasdaq: BTAI) has announced positive results from a correlation study supporting the efficacy outcomes of its SERENITY At-Home trial, according to a BioSpace press release.

The results demonstrated a strong correlation between the clinician assessments and the patient or caregiver (informant) rated outcomes, with a correlation coefficient (ρ) of 0.89 for patients and 0.88 for informants, both with p-values less than 0.0001. These findings support the use of mCGI-S to assess efficacy in the outpatient setting, providing additional data to be included in the company's upcoming supplemental New Drug Application (sNDA) submission, planned for the first quarter of 2026.

The study used the modified CGI-S scale, a 4-point scale where 0 indicates no agitation and scores of 1–3 describe increasing severities of agitation. This scale was developed to facilitate implementation by patients and informants in the home setting. The PEC, a 5-item assessment for rating acute psychomotor agitation, was used as the standard method for measuring acute agitation associated with schizophrenia and bipolar disorder.

The study's results are significant as they provide further support for the efficacy of BXCL501, an investigational proprietary, orally dissolving film formulation of dexmedetomidine, which is under investigation for the acute treatment of agitation associated with Alzheimer’s dementia and bipolar I or II disorder or schizophrenia in the at-home setting.

The positive results from the correlation study, along with the data from the SERENITY At-Home trial, will be included in the sNDA submission to the FDA. The company has also been granted Breakthrough Therapy designation for the acute treatment of agitation associated with dementia and Fast Track designation for the acute treatment of agitation associated with schizophrenia, bipolar disorders, and dementia.