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Home › PDUFA Calendar › ABBV

ABBV PDUFA Date: JUVMO (Tavapadon)

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 September 25, 2026 (FDA record; announced September 28, 2026). Decision page with the source and measured reaction.
FDA decision Approved September 25, 2026 · AbbVie Inc. · Early Parkinson’s disease
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The story

Tavapadon was approved by the FDA on September 25, 2026 to treat Early Parkinson’s disease.
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)EXEL . 2026-12-03Same month decision . XL092 with atezolizumab
Plain-English summary compiled by pdufa.bio from public FDA, SEC and company sources. Informational only - not investment advice.

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

$236.19$197.38
Price path to 2026-06-19. Green = local high, red = low/sell-off. Historical price action, not a forecast.

Key facts

FDA decisionApproved September 25, 2026
Drug / candidateTavapadon
IndicationEarly Parkinson’s disease
CompanyAbbVie Inc.
Market-cap tierLarge
Cohort decision-day move (history)±1% median
ClinicalTrials.govNCT04223193

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FAQ

What did the FDA decide on ABBV's Tavapadon?
The FDA decided ABBV's (AbbVie Inc.) application for Tavapadon on September 28, 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 ABBV's drug Tavapadon?
Tavapadon is AbbVie Inc.'s drug, approved by the FDA on September 25, 2026 for Early Parkinson’s disease.
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.