Florquinitau (MK-6240)

Oct. 28, 2025: Lantheus Holdings, Inc. (NASDAQ: LNTH) announced the FDA accepted its New Drug Application (NDA) for MK-6240, an investigational F18-labeled tau-targeted PET imaging agent intended to detect tau neurofibrillary tangle pathology in patients with cognitive impairment being evaluated for Alzheimer’s disease. MK-6240 previously received FDA Fast Track designation. The FDA set a PDUFA target action date of Aug. 13, 2026.

The NDA is supported by data from two pivotal Phase 3 trials in early Alzheimer’s disease; the studies met their co-primary endpoints for sensitivity and specificity to detect tau NFTs.