This page aggregates KZIA's FDA catalysts from pdufa.bio's own calendar and decision archive. Each item links to its source page. Facts and dates only; verify against primary FDA / SEC / company filings.
Computed from this stock's own daily closing prices, on the same T-120 basis as the run-up study: the baseline is the close 120 trading sessions before the eve of the decision. These are measurements of what already happened, not predictions.
| Decision | Outcome | T-120 to eve | T-120 to peak |
|---|---|---|---|
| 2025-11-18 | CRL | +70.8% | +221.1% |
| 2025-01-02 | APPROVAL | -85.7% | +0.0% |
Q4 2027. The next catalyst for Kazia Therapeutics LTD is paxalisib Stage IV TNBC study (readout). That date is . Dates are taken from FDA notices, company filings or ClinicalTrials.gov, and we do not publish a specific day when the source only gives a month or a quarter.
Yes, 2 in our archive: 1 approval(s) and 1 Complete Response Letter(s). The most recent was on November 18, 2025 and was a Complete Response Letter. Each one has its own page with the source document and the share-price reaction we measured.
We have no measured history for KZIA itself. Across the whole study of 1,875 FDA decisions, the median stock rose 18.1% at its best point in the 120 trading days before the decision, but was only 2.4% higher the day before it. Most of the move happened before the answer arrived and was largely given back.
FDA publications, company filings with the SEC, company press releases and ClinicalTrials.gov, with share prices measured from daily closing data. Every date and outcome links the document it came from. Where an outcome was inferred from the price reaction rather than read from a filing, the page says so on its face.