TAUKLARIFY (Florquinitau F 18 injection (MK-6240))

Aug. 14, 2026: Lantheus Holdings (NASDAQ: LNTH) announced FDA approval of TAUKLARIFY (florquinitau F 18 injection; MK-6240), a tau PET radiodiagnostic for brain imaging in adults with cognitive impairment being evaluated for Alzheimer’s disease to identify tau neurofibrillary tangle pathology. The label includes a limitation that safety and effectiveness have not been established for non-Alzheimer’s tauopathies.

Approval was supported by two blinded read studies using TAUKLARIFY PET images from more than 500 subjects across three trials. In Study 1 (n=279), positive percent agreement ranged from 80% to 88% and negative percent agreement from 98% to 99%; inter-reader agreement was high (generalized Fleiss’ kappa 0.92, 95% CI 0.89-0.96). In Study 2 (n=338), positive percent agreement ranged from 68% to 82% and negative percent agreement from 93% to 99%; inter-reader agreement was also high (kappa 0.86, 95% CI 0.82-0.89).

Safety was evaluated in 1,734 subjects; the most common adverse reactions were headache (0.7%), nausea (0.2%), injection site reactions (0.1%), dizziness (0.1%), and abdominal discomfort (0.1%). Lantheus said it will continue supporting Alzheimer’s therapeutic programs through Pharma Solutions while assessing the path toward broader commercial availability.