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Home › FDA Decisions › IPSEY 2025-03-26

IPSEY FDA Decision Approved · 2025-03-26

Updated ·next FDA decision on the calendar

Price into the decision (T-120)

PDUFA 3/26/25$32.035$27.2810/9/24
Daily close, T-120 (10/9/24) through T+5. Run-up high $32.035 on 1/21/25, low $27.28 on 12/27/24 (T-120 to T-1). FDA decision 3/26/25. Historical price action, not a forecast.

Decision facts

FDA decision date2025-03-26
DrugCABOMETYX (cabozantinib) - (CABINET)
IndicationAdvanced Neuroendocrine Tumors
Outcome✓ Approvedprimary-sourced
Decision-day move-2.4%
T-120 run-up (low→high)+14.0% ($27.28→$32.03)
ValidationVerified 2026-08-12: Drugs@FDA, application NDA208692, action date 2025-03-26
Market-cap tierSmall
Cohort decision-day move (history)3.6% median (n=280)

Cohort move is the historical median absolute decision-day move for this market-cap tier across our run-up study. History, not a prediction.

See the full 2026 PDUFA calendar →

Questions

Was CABOMETYX (cabozantinib) - (CABINET) approved by the FDA?

Yes. The FDA approved the application for CABOMETYX (cabozantinib) - (CABINET) on March 26, 2025. The primary source is linked on this page.

What was CABOMETYX (cabozantinib) - (CABINET) under FDA review for?

The application covered Advanced Neuroendocrine Tumors. The FDA approved the application on March 26, 2025.

How did IPSEY stock react to the FDA decision?

On the decision day IPSEY moved -2.4%. That is the recorded reaction to this specific event -- historical measurement, not a prediction, and not investment advice.