pdufa.bio
CalendarDecisionsApprovals/yrTrial oddsLearnResearchMethodology
Home › PDUFA Calendar › LNTH

LNTH PDUFA Date: LNTH-2501 (Gallium-68 edotreotide)

FDA decision (PDUFA) target 2026-06-29 · Lantheus Holdings Inc. · Neuroendocrine tumors (NETs) in adult and pediatric patients

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 PDUFA target date2026-06-29
Drug / candidateLNTH-2501 (Gallium-68 edotreotide)
IndicationNeuroendocrine tumors (NETs) in adult and pediatric patients
CompanyLantheus Holdings Inc.
Market-cap tierMid
Cohort decision-day move (history)±2% median
ClinicalTrials.govNCT02375464 · n/a

New to FDA decisions? Read what a PDUFA date is and how often the FDA approves drugs.

Track this live → price, options (expected move & IV) and the full dashboard
Opens the pdufa.bio app (private beta)

FAQ

When is the LNTH PDUFA date?
The FDA PDUFA target date for LNTH (Lantheus Holdings Inc.) is 2026-06-29 for LNTH-2501 (Gallium-68 edotreotide). Dates are company/FDA-sourced and can slip — verify against primary filings.
What is LNTH's drug LNTH-2501 (Gallium-68 edotreotide)?
LNTH-2501 (Gallium-68 edotreotide) is Lantheus Holdings Inc.'s candidate under FDA review for Neuroendocrine tumors (NETs) in adult and pediatric patients.
What typically happens to a mid-cap stock into a PDUFA date?
Historically, mid-cap names had a median decision-day move around ±2% (694-PDUFA cohort, 2024–26). This is historical context by market-cap tier, not a prediction for this drug.