MK-6240 was approved by the FDA on August 13, 2026 for PET imaging of tau neurofibrillary tangle pathology in adults with cognitive impairment being evaluated for Alzheimer's disease.
TAUKLARIFY (florquinitau F 18), an F18-labeled tau PET imaging agent for Alzheimer's disease, approved on its Aug 13 2026 PDUFA date (announced Aug 14 2026).
The PDUFA target action date was August 13, 2026. Lantheus announced the approval the following morning, August 14, 2026. TAUKLARIFY is a radiodiagnostic agent, not a therapeutic: it identifies patients with tau neurofibrillary tangle pathology on PET imaging. Approval was supported by two blinded read studies analyzing images from more than 500 subjects across three clinical trials. MK-6240 previously held FDA fast-track status.
Run-up figures are the stock's own daily closing path over the 120 trading days before the decision, from our price history. Cohort move is the historical median absolute decision-day move for this market-cap tier. History, not a prediction.
Primary source: FDA approval letter, NDA 220496, August 13, 2026 (Drugs@FDA); announced in Lantheus press release, August 14, 2026
FDA record of the action: the FDA approved on August 13, 2026, per NDA 220496 ORIG-1 (FDA letter). The sponsor announced it the same day. Action dates on pdufa.bio come from the FDA's own record, not the press release. Every FDA action we hold, by FDA date: FDA approval letters.
Yes. The FDA approved the application for TAUKLARIFY (florquinitau F 18 injection, MK-6240) on August 13, 2026, per the FDA's own record. The primary source is linked on this page.
TAUKLARIFY (florquinitau F 18 injection, MK-6240) is a Lantheus Holdings, Inc. (LNTH) program. The FDA decision came on August 13, 2026; the company's own announcement is linked on this page.
Measured over the 120 trading days before the decision (T-120 to T-1), LNTH moved +37.6%. That is the recorded price path into this specific event. Historical measurement, not a prediction, and not investment advice.