28 October 2025 - Enigma Biomedical today announced that the FDA has accepted a new drug application for MK-6240 (florquinitau F-18), their tau positron emission tomography Alzheimer’s disease radiodiaganostic.
The FDA previously granted MK-6240 fast track status, which is a recognition of the potential to address an important unmet need. MK-6240 specifically targets a pathological form of tau called tau neurofibrillary tangles, a key hallmark in Alzheimer’s disease.