Note: Lantheus IR release (Oct 28, 2025): FDA accepted the NDA for MK-6240, an F 18-labeled tau-targeted PET imaging agent; PDUFA target action date August 13, 2026; Fast Track designation. Corroborated in Lantheus 8-K Ex-99.1 filed Nov 6, 2025 (https://www.sec.gov/Archives/edgar/data/1521036/000119312525268103/lnth-ex99_1.htm) and repeated in the FY2025 10-K and Q1 2026 10-Q. Supported by two pivotal Phase 3 trials that met sensitivity and specificity endpoints. This is the real drug behind the pdufa-calendar.json parse-error row 'Lantheus Holdings, Inc. / drugName: LNTH' at 2026-08-13.
Drug Information
- Drug Name
- MK-6240 (CT.gov)
- Application Type
- NDA
- FDA Designations
- Fast Track
- Indication
- PET imaging for detection of tau neurofibrillary tangle pathology in patients with cognitive impairment being evaluated for Alzheimer's disease
Filing Details
- Company
- Lantheus Holdings, Inc. →
- Stock Ticker
- LNTH
- SEC CIK
- Source
- Company IR →
What is a PDUFA Date?
A PDUFA (Prescription Drug User Fee Act) date is the FDA's target deadline to complete review of a drug application. The FDA aims to make an approval decision by this date.
- Standard Review: 10 months from filing acceptance
- Priority Review: 6 months from filing acceptance
- Possible Outcomes: Approval, Complete Response Letter (CRL), or extension
Explore Lantheus Holdings, Inc.
View Lantheus Holdings, Inc.'s full pipeline, approved drugs, and clinical trials.
Data sourced from SEC EDGAR filings. Last updated: 2026-08-02. Report an issue