JUVMO (tavapadon) was approved by the FDA on September 25, 2026 for Parkinson's disease in adults, the 43rd novel drug approval of 2026 on the FDA's Novel Drug Approvals list.
AbbVie announced the approval on September 28, 2026 and describes JUVMO as the first selective D1/D5 receptor agonist approved for adults with Parkinson's disease.
The FDA's approval letter for NDA 220415 is dated September 25, 2026 (Drugs@FDA). AbbVie announced the approval in a release on Monday, September 28, 2026, and expects JUVMO to be available in the U.S. in October 2026. AbbVie never published a PDUFA goal date for tavapadon, so no early or late margin is computed for this decision. JUVMO is taken once daily with or without levodopa; the approval is supported by the Phase 3 TEMPO program (TEMPO-1, TEMPO-2 and TEMPO-3, with the TEMPO-4 open-label extension).
Run-up figures are the stock's own daily closing path over the 120 trading days before the decision, from our price history. Cohort move is the historical median absolute decision-day move for this market-cap tier. History, not a prediction.
Primary source: FDA approval letter, NDA 220415, September 25, 2026
FDA record of the action: the FDA approved on September 25, 2026, per NDA 220415 ORIG-1 (FDA letter). The sponsor announced it on September 28, 2026. Action dates on pdufa.bio come from the FDA's own record, not the press release. Every FDA action we hold, by FDA date: FDA approval letters.
Yes. The FDA approved the application for JUVMO (tavapadon) on September 25, 2026, per the FDA's own record. The company announced it on September 28, 2026. The primary source is linked on this page.
JUVMO (tavapadon) is an AbbVie (ABBV) program. The FDA decision came on September 25, 2026; the FDA's own record of the decision is linked on this page.
Measured over the 120 trading days before the decision (T-120 to T-1), ABBV moved +28.1%. That is the recorded price path into this specific event. Historical measurement, not a prediction, and not investment advice.