Clean audit frees Bioxcel for potential sNDA in Alzheimer’s agitation
Oct. 25, 2023
Bioxcel Therapeutics Inc. said a third-party audit of data from its Tranquility II phase III study came back clean, potentially positioning the firm to submit the statistically significant results in a supplemental NDA seeking approval of BXCL-501 in treating agitation associated with dementia in probable Alzheimer’s disease.