What To Know: The trial evaluates BXCL501 for the acute treatment of agitation associated with Alzheimer's dementia. The FDA released an Establishment Inspection Report and designated the site with a “Voluntary Action Indicated” status under 21 C.F.R.20.64(d)(3), signaling that while some minor issues may have been noted, they do not require regulatory action.
The company has also received FDA feedback on the protocol for its TRANQUILITY In-Care Phase 3 trial, which is set to evaluate BXCL501 for agitation in Alzheimer's patients residing in care facilities. The TRANQUILITY In-Care trial will assess the efficacy and safety of a 60 mcg dose of BXCL501 over 12 weeks in patients with mild to severe Alzheimer's-related dementia.
BTAI Price Action: BioXcel shares were up 117.1% at $4.68 at the time of writing, according to Benzinga pro.
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