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TAK PDUFA Date: Oveporexton (TAK-861-2001)

FDA decision (PDUFA) target 2026-09-30 · Takeda Pharmaceutical Company Limited American Depositary Shares (each representing 1/2 of a share of) · Narcolepsy type 1 (NT1)

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

$18.8$15.03
Price path to 2026-06-19. Green = local high, red = low/sell-off. Historical price action, not a forecast.

Key facts

FDA PDUFA target date2026-09-30
Drug / candidateOveporexton (TAK-861-2001)
IndicationNarcolepsy type 1 (NT1)
CompanyTakeda Pharmaceutical Company Limited American Depositary Shares (each representing 1/2 of a share of)
Market-cap tierLarge
Cohort decision-day move (history)±1% median
ClinicalTrials.govNCT05687903 · completed

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FAQ

When is the TAK PDUFA date?
The FDA PDUFA target date for TAK (Takeda Pharmaceutical Company Limited American Depositary Shares (each representing 1/2 of a share of)) is 2026-09-30 for Oveporexton (TAK-861-2001). Dates are company/FDA-sourced and can slip — verify against primary filings.
What is TAK's drug Oveporexton (TAK-861-2001)?
Oveporexton (TAK-861-2001) is Takeda Pharmaceutical Company Limited American Depositary Shares (each representing 1/2 of a share of)'s candidate under FDA review for Narcolepsy type 1 (NT1).
What typically happens to a large-cap stock into a PDUFA date?
Historically, large-cap names had a median decision-day move around ±1% (694-PDUFA cohort, 2024–26). This is historical context by market-cap tier, not a prediction for this drug.