MK-6240 (florquinitau)
Alzheimer's disease · Patients with cognitive impairment being evaluated for Alzheimer's disease
LNTH · Lantheus Holdings, Inc.
Regulatory designations
Full timeline
3 milestonesFDA decision expected
PDUFA target action date for the MK-6240 NDA in Alzheimer's disease diagnostics.
Lantheus — NDA acceptance and PDUFA date↗FDA accepted the MK-6240 NDA
FDA accepted the application for the F18-labeled tau PET imaging agent and assigned an August 13, 2026 action date.
Lantheus — FDA acceptance of the MK-6240 NDA↗Two pivotal studies met co-primary endpoints
MK-6240 met the co-primary sensitivity and specificity endpoints in two pivotal studies supporting the NDA.
Lantheus — MK-6240 pivotal study results↗Related News
No related news available.