Lantheus Holdings's NDA For MK-6240 Wins FDA Approval

(RTTNews) - Lantheus Holdings, Inc. (LNTH), Tuesday announced that the U.S. Food and Drug Administration has accepted its New Drug Application for MK-6240, which is designed to target aggregated tau protein in the form of neurofibrillary tangles in patients with cognitive impairment being evaluated for Alzheimer's disease.

The submission was supported by data from two pivotal Phase 3 clinical trials, which evaluated MK-6240's performance in detecting tau pathology in early Alzheimer's disease.

The studies met co-primary endpoints of sensitivity and specificity to detect tau NFTs

The FDA has set a Prescription Drug User Fee Act target action date of August 13, 2026.

CEO Brian Markison noted, "If approved, MK-6240 would complement beta-amyloid PET imaging and emerging blood-based diagnostics, helping guide treatment strategies for providers and patients."

Currently, LNTH is trading at $56.65, down 2.66 percent on the Nasdaq.