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Home › FDA Decisions › KZIA 2025-01-02

KZIA FDA Decision Approved · 2025-01-02

Updated ·next FDA decision on the calendar

Price into the decision (T-120)

PDUFA 1/2/25$45$8.857/18/24
Daily close, T-120 (7/18/24) through T+5. Run-up high $45 on 7/18/24, low $8.85 on 1/1/25 (T-120 to T-1). FDA decision 1/2/25. Historical price action, not a forecast.

Decision facts

FDA decision date2025-01-02
DrugPaxalisib (GDC-0084) - (GBM AGILE)
IndicationGlioblastoma multiforme
Outcome✓ Approvedprimary-sourced
Decision-day move-1.4%
T-120 run-up (low→high)+79.0% ($8.73→$33.9)
ValidationVerified 2026-08-12: SEC filing 0001193125-25-005004 of 2025-01-13 containing 'approval of'
Market-cap tierMicro
Cohort decision-day move (history)4.6% median (n=308)

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 Paxalisib (GDC-0084) - (GBM AGILE) approved by the FDA?

Yes. The FDA approved the application for Paxalisib (GDC-0084) - (GBM AGILE) on January 2, 2025. The primary source is linked on this page.

What was Paxalisib (GDC-0084) - (GBM AGILE) under FDA review for?

The application covered Glioblastoma multiforme. The FDA approved the application on January 2, 2025.

How did KZIA stock react to the FDA decision?

On the decision day KZIA moved -1.4%. That is the recorded reaction to this specific event -- historical measurement, not a prediction, and not investment advice.