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).
Run-up into the decision (T-120 → T+5)
Daily close, T-120 (2/19/26) through T+0. Run-up high $110.94 on 6/30/26, low $72.56 on 3/6/26 (T-120 to T-1). FDA decision 8/13/26. Historical price action, not a forecast.
Key facts
FDA decision date2026-08-13
OutcomeApproved
Drug / candidateTAUKLARIFY (florquinitau F 18 injection, MK-6240)
IndicationPET imaging of tau neurofibrillary tangle pathology in adults with cognitive impairment being evaluated for Alzheimer's disease
CompanyLantheus Holdings, Inc.
Market-cap tierMid
120-day run-up (T-120→T-1)+37.6%
Cohort decision-day move (history)2.1% median (n=230)
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.
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