Enigma Biomedical USA announces FDA acceptance of new drug application for florquinitau F-18 (MK-6240), a tau PET Alzheimer’s disease radiodiagnostic

Enigma Biomedical

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.

Read Enigma Biomedical press release

Michael Wonder

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Michael Wonder

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US , Dossier , Diagnostic agent