MedPath

Florquinitau F18

Generic Name
Florquinitau F18

Lantheus' Alzheimer's Radiodiagnostic MK-6240 Achieves Pivotal Study Success, NDA Filing Planned

• Lantheus Holdings announced its F18-labeled tau PET radiodiagnostic MK-6240 successfully met co-primary endpoints in two pivotal studies, demonstrating both sensitivity and specificity for detecting tau pathology in Alzheimer's disease. • The company plans to file a New Drug Application with the FDA in Q3 2025, potentially advancing a diagnostic tool that targets neurofibrillary tangles, a key hallmark of Alzheimer's disease. • If approved, MK-6240 could significantly impact Alzheimer's management by enabling earlier detection, patient staging, therapy selection, and monitoring, with the U.S. Alzheimer's radiodiagnostic market projected to reach $1.5 billion by 2030.
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