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JUVMO (tavapadon)

Page updated ·next FDA decision on the calendar ·Data as of Nov 5, 2026 9:00 PM ET

JUVMO (tavapadon) is an AbbVie program in parkinson's disease in adults (once daily, with or without levodopa). The FDA approved it on Sep 25, 2026. 1 FDA decision on record below. Every date links its source.

ABBV catalyst hub

All upcoming FDA decision dates on the 2026 PDUFA calendar

About this program

JUVMO is the brand name of tavapadon (the name it carries since FDA approval); this page tracks both names. FDA approval tracked on pdufa.bio: parkinson's disease in adults (once daily, with or without levodopa) (approved Sep 25, 2026). Earlier approvals may not be listed here; the FDA label is the full record. Sponsor: AbbVie (ABBV). Approval record: NDA 220415, approved September 25, 2026 (FDA letter); AbbVie announced it September 28, 2026. AbbVie describes JUVMO as the first selective D1/D5 receptor agonist approved for adults with Parkinson's disease, taken once daily with or without levodopa, and expects U.S. availability in October 2026. Supported by the Phase 3 TEMPO program (TEMPO-1, -2 and -3, with the TEMPO-4 open-label extension). Market-cap tier at the time we tracked it: Large. We track 1 catalyst event for this program: 0 upcoming and 1 in the record. A PDUFA date is the FDA's target date to complete review of a marketing application; a readout is the sponsor's expected date for clinical trial results. What a PDUFA date is · why we do not compare trial results across drugs.

Catalyst history

FDA decision · Sep 28, 2026 ✓ ApprovedABBV

Questions

When is JUVMO (tavapadon)'s next FDA decision or readout?

No upcoming catalyst is on our calendar for JUVMO (tavapadon); 1 FDA decision is on record below.

What happened at JUVMO (tavapadon)'s most recent FDA decision?

On Sep 28, 2026 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.

What is JUVMO (tavapadon) used for?

In our records JUVMO (tavapadon) is FDA-approved for parkinson's disease in adults (once daily, with or without levodopa) (approved Sep 25, 2026). Other approved uses may not be tracked here; the FDA label is the full record.

Who makes JUVMO (tavapadon)?

AbbVie (ABBV).

Has JUVMO (tavapadon) been approved by the FDA?

Yes. The FDA approved an application for JUVMO (tavapadon) on Sep 28, 2026; the decision page linked above carries the source.

Where does this data come from?

FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.

Facts and dates only; not investment advice. Verify against primary FDA, SEC and company filings. pdufa.bio is not affiliated with the FDA.
About · Corrections · Methodology

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