Enigma Biomedical USA Announces FDA Acceptance of New Drug Application for Florquinitau F-18 (MK-6240), a Tau PET Radiodiagnostic for Alzheimer’s Disease
Wednesday, October 29, 2025
Enigma Biomedical USA (EB USA) has announced that the US Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for florquinitau F-18 (MK-6240), a Tau Positron Emission Tomography (PET) radiodiagnostic designed for Alzheimer’s disease. The FDA had previously granted MK-6240 Fast Track designation, recognising its potential to address a significant unmet medical need.
MK-6240 targets tau neurofibrillary tangles (NFTs), a pathological form of tau protein that serves as a key indicator of Alzheimer’s disease. In April 2025, Lantheus reported that MK-6240 met its co-primary endpoints in two pivotal studies and subsequently filed the NDA in the third quarter of 2025. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of 13 August 2026.
Lantheus acquired the rights to MK-6240 in 2023 and partnered with Enigma Biomedical to support its continued development. The acceptance of the NDA marks a significant milestone in advancing diagnostic tools for neurodegenerative diseases. It reinforces both companies’ shared commitment to developing technologies that can improve early disease detection and support the creation of disease-modifying therapies.
MK-6240 is designed to detect aggregated tau protein in the form of neurofibrillary tangles, a defining feature of several neurodegenerative disorders, including Alzheimer’s disease. The compound has shown strong affinity for tau with minimal off-target binding in both preclinical and clinical studies.
Currently used in nearly 100 active clinical trials, MK-6240 is expected to enhance early diagnosis, enable better patient staging, guide treatment selection, and support disease monitoring. It may also contribute to establishing tau as a potential surrogate marker for assessing treatment effectiveness in Alzheimer’s research.
Source: businesswire.com
