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Home › PDUFA Calendar › TAK

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

Updated ·next FDA decision on the calendar
✓ Approved · the FDA decided this application on August 5, 2026. Decision page with the source and measured reaction.
FDA decision Approved August 5, 2026 · Takeda Pharmaceutical Company Limited American Depositary Shares (each representing 1/2 of a share of) · Narcolepsy type 1 (NT1)
More CNS & Neurology FDA decisions →

The story

Oveporexton (TAK-861-2001) was approved by the FDA on August 5, 2026 to treat share of) · Narcolepsy type 1 (NT1).
Full PDUFA calendar ->Every upcoming FDA decision date, by monthNRXP . 2026-07-29Same area: Neurology . KETAFREELNTH-florquinitau . 2026-08-13Same area: Neurology . Florquinitau (MK-6240)TLX . 2026-09-11Same month decision . TLX101-Px
Plain-English summary compiled by pdufa.bio from public FDA, SEC and company sources. Informational only - not investment advice.

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 decisionApproved August 5, 2026
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
See the full 2026 PDUFA calendar →

FAQ

What did the FDA decide on TAK's Oveporexton (TAK-861-2001)?
The FDA decided TAK's (Takeda Pharmaceutical Company Limited American Depositary Shares (each representing 1/2 of a share of)) application for Oveporexton (TAK-861-2001) on August 5, 2026: Approved. We do not state a goal date for this application: the date we had carried was never sourced to a filing or company release. Verify against the linked primary source.
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 drug, approved by the FDA on August 5, 2026 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% (763-PDUFA cohort, 2024-26). This is historical context by market-cap tier, not a prediction for this drug.
Decision-day move · large-cap cohortn=790 · median +0.0% · 50% up
under -30%: 2 of 790 (0%)<-30-30 to -15%: 2 of 790 (0%)-15 to -7%: 6 of 790 (1%)-7 to -3%: 29 of 790 (4%)-3 to +3%: 707 of 790 (89%)±3+3 to +7%: 35 of 790 (4%)+7 to +15%: 5 of 790 (1%)+15 to +30%: 2 of 790 (0%)over +30%: 2 of 790 (0%)>+30
Distribution of next-day % moves after the FDA decision for large-cap PDUFAs (2020–26). Red = down, green = up, blue = flat (±3%). Historical dispersion, not a forecast.