Lantheus Holdings Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for MK-6240, an investigational F18-labeled tau-targeted PET imaging agent designed to detect tau neurofibrillary tangle pathology in patients with cognitive impairment being evaluated for Alzheimer's disease. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of August 13, 2026. MK-6240 previously received Fast Track designation and its NDA submission is supported by positive results from two pivotal Phase 3 clinical trials. No grant or funding involving multiple organizations was mentioned in the announcement.
Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Lantheus Holdings Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9563056-en) on October 28, 2025, and is solely responsible for the information contained therein.