Page updated ·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 (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.
Every FDA approval letter and released Complete Response Letter we hold, by FDA action date: FDA approval letters.
Questions
Was Paxalisib (GDC-0084) approved by the FDA?
Yes. The approval of the application for Paxalisib (GDC-0084) was announced on January 2, 2025; pdufa.bio holds no FDA record stating the exact day the FDA acted. The primary source is linked on this page.
What was Paxalisib (GDC-0084) 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.