FDA Accepts Lantheus' NDA For MK-6240, Investigational F18-Labeled Tau-Targeted PET Imaging Agent For Detection Of Tau NFT Pathology In Patients With Alzheimer's Disease; PDUFA Date Set For August 13, 2026

Author: Benzinga Newsdesk | October 28, 2025 07:36am

Lantheus Holdings, Inc. ("Lantheus") (NASDAQ:LNTH), the leading radiopharmaceutical-focused company committed to enabling clinicians to Find, Fight and Follow disease to deliver better patient outcomes, today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for MK-6240, the company's investigational F18-labeled tau-targeted Positron Emission Tomography (PET) imaging agent for the detection of tau neurofibrillary tangle (NFT) 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 (PDUFA) target action date of August 13, 2026.

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