Lantheus received FDA acceptance of its New Drug Application for MK‑6240, a fluorine‑18 labeled PET imaging agent that detects tau neurofibrillary tangle pathology in patients with cognitive impairment being evaluated for Alzheimer’s disease.
The acceptance establishes a PDUFA target decision date of August 13 2026. The NDA is supported by data from two pivotal Phase 3 trials that met co‑primary endpoints of sensitivity and specificity for detecting tau pathology.
MK‑6240 was acquired by Lantheus in 2023 through its purchase of Cerveau Technologies and carries Fast Track designation, underscoring its potential to address unmet diagnostic needs.
The approval would complement Lantheus’s existing beta‑amyloid PET agent Neuraceq (florbetaben) and support the company’s strategy to expand into Alzheimer’s diagnostics, a market projected to reach $1.5 billion annually by 2030.
Lantheus is also involved in the NIH‑funded CLARiTI study, a five‑year, multi‑site trial of 2,000 participants, and has recently acquired Life Molecular Imaging, adding Neuraceq to its portfolio.
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