Lantheus announces FDA acceptance of NDA for MK-6240

Lantheus (LNTH) Holdings announced that the U.S. Food and Drug Administration has accepted its New Drug Application for MK-6240, the company’s investigational F18-labeled tau-targeted Positron Emission Tomography imaging agent for the detection of tau neurofibrillary tangle pathology in patients with cognitive impairment being evaluated for Alzheimer’s disease. MK-6240 previously received Fast Track designation from the FDA for its potential to address an unmet medical need in Alzheimer’s disease diagnostics. The FDA has set a Prescription Drug User Fee Act target action date of August 13, 2026. The NDA submission is supported by data from two pivotal Phase 3 clinical trials, which evaluated MK-6240’s performance in detecting tau pathology in early Alzheimer’s disease. These studies met their co-primary endpoints of sensitivity and specificity to detect tau NFTs.