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Lantheus Says New Drug Application for Alzheimer's Disease Imaging Agent Accepted by FDA
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Lantheus Says New Drug Application for Alzheimer's Disease Imaging Agent Accepted by FDA
Oct 28, 2025 7:49 AM

10:12 AM EDT, 10/28/2025 (MT Newswires) -- Lantheus ( LNTH ) said Tuesday its new drug application for K-6240, an investigational Positron Emission Tomography imaging agent targeting tau in Alzheimer's Disease, was accepted by the US Food and Drug Administration.

The agency set a target action date of Aug. 13, 2026, for the imaging agent, Lantheus ( LNTH ) said.

The submission is supported by data from two pivotal phase 3 clinical trials that assessed MK-6240's performance in detecting tau pathology in early Alzheimer's disease, the company said.

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