Will the FDA approve the Alzheimer's brain-imaging agent MK-6240 by its Aug 13 decision date?
100% of users predicted YES — the community got this one right. 2 predictions cast.
The Food and Drug Administration approved Tauklarify (florquinitau F 18 injection, developmental name MK-6240) on Friday, August 14, 2026, clearing the tau-targeted PET imaging agent for adults with cognitive impairment being evaluated for Alzheimer's disease. Lantheus Holdings and its imaging partner Enigma Biomedical USA jointly announced the approval, which came in connection with the FDA's Prescription Drug User Fee Act target action date of August 13, 2026, after the agency had accepted the new drug application in October 2025. The agent allows clinicians to visualize tau neurofibrillary tangle pathology, a hallmark of Alzheimer's disease, and data cited by the companies showed MK-6240 outperforming the older tracer flortaucipir at detecting neocortical tau positivity. The approval carries a limitation of use, noting that safety and effectiveness have not been established for evaluating non-Alzheimer's tauopathies. The tracer had already been used in nearly 100 active clinical trials ahead of the decision. Because the FDA action was tied to the agency's August 13 target date and publicly confirmed before the market's resolution window closed, the question resolved yes, matching the community's unanimous prediction.