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Home › PDUFA Calendar › LNTH

LNTH PDUFA Date: Florquinitau (MK-6240)

Page updated ·next FDA decision on the calendar ·Data as of Oct 11, 2026 9:31 PM ET
✓ Approved · the FDA decided this application on August 13, 2026 on its goal date. Decision page with the source and measured reaction.
FDA decision Approved August 13, 2026 · Lantheus Holdings Inc. · Alzheimer's disease
More CNS & Neurology FDA decisions →All August 2026 PDUFA dates →

The story

Florquinitau (MK-6240) was approved by the FDA on August 13, 2026 to treat Alzheimer's disease.
Full PDUFA calendar ->Every upcoming FDA decision date, by monthNRXP . 2026-07-29Same area: Neurology . KETAFREECAPR . 2026-08-22Same area: Neurology . Deramiocel (CAP-1002)MRNA . 2026-08-05Same month decision . mRNA-1010
Plain-English summary compiled by pdufa.bio from public FDA, SEC and company sources. Informational only - not investment advice.

LNTH run-up into the PDUFA (last ~120 days)

$105.03$72.56
Price path to 2026-06-19. Green = local high, red = low/sell-off. Historical price action, not a forecast.

Key facts

FDA decisionApproved August 13, 2026
FDA goal date2026-08-13
Drug / candidateFlorquinitau (MK-6240)
IndicationAlzheimer's disease
CompanyLantheus Holdings Inc.
Market-cap tierMid
Cohort decision-day move (history)±2% median
ClinicalTrials.govNot listed

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See the full 2026 PDUFA calendar →

FAQ

What did the FDA decide on LNTH's Florquinitau (MK-6240)?
The FDA decided LNTH's (Lantheus Holdings Inc.) application for Florquinitau (MK-6240) on August 13, 2026: Approved. The FDA goal date for this application was 2026-08-13. Verify against the linked primary source.
What is LNTH's drug Florquinitau (MK-6240)?
Florquinitau (MK-6240) is Lantheus Holdings Inc.'s drug, approved by the FDA on August 13, 2026 for Alzheimer's disease.
What typically happens to a mid-cap stock into a PDUFA date?
Historically, mid-cap names had a median decision-day move around ±2% (763-PDUFA cohort, 2024-26). This is historical context by market-cap tier, not a prediction for this drug.
Decision-day move · mid-cap cohortn=222 · median -0.0% · 49% up
under -30%: 5 of 222 (2%)<-30-30 to -15%: 6 of 222 (3%)-15 to -7%: 7 of 222 (3%)-7 to -3%: 21 of 222 (9%)-3 to +3%: 134 of 222 (60%)±3+3 to +7%: 34 of 222 (15%)+7 to +15%: 9 of 222 (4%)+15 to +30%: 1 of 222 (0%)over +30%: 5 of 222 (2%)>+30
Distribution of next-day % moves after the FDA decision for mid-cap PDUFAs (2020–26). Red = down, green = up, blue = flat (±3%). Historical dispersion, not a forecast.