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IPSEY FDA Decision Approved · 2025-03-26

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

Price into the decision (T-120)

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)3.7% median (n=302)

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 →

Every FDA approval letter and released Complete Response Letter we hold, by FDA action date: FDA approval letters.

Questions

Was CABOMETYX (cabozantinib) approved by the FDA?

Yes. The FDA approved the application for CABOMETYX (cabozantinib) on March 26, 2025, per the FDA's own record. The primary source is linked on this page.

What was CABOMETYX (cabozantinib) 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.