Methodology
How every date on this site gets here, and what its status label means.
The FDA does not publish pending PDUFA dates. A date only becomes public because the company disclosed it — in a press release, an 8-K, or a 6-K. So that is where we look, and the filing we read is the link you see on every row. Why the FDA keeps them private is explained in the guides.
Regulatory dates come from SEC EDGAR full-text search across recent 8-K and 6-K filings, and from the FDA's own advisory committee calendar. Clinical readout timing comes from the same filings — what the company itself guided to, quoted on the row — cross-checked where useful against ClinicalTrials.gov, whose primary completion dates are planning estimates rather than readout commitments. Approval outcomes are confirmed through openFDA. Whether a stock has listed options is taken from the OCC's directory of listed products. Nothing on this site is scraped from another catalyst site. The steps are the same ones in our guide to checking a date on EDGAR yourself.
Verified means a person opened the linked filing and read the sentence containing the date. Auto-extracted means the date was pulled straight out of that filing by our extractor and the sentence it came from is quoted on the row, but no person has read it yet — the source is primary, the reading is not yet confirmed. Reported means the date came from a secondary source and is queued for both. Needs check means we have spotted something that needs resolving before the row can be trusted, and the note says what.
Of the 241 catalysts currently listed, 233 are verified against a primary filing. That ratio is published deliberately: a number you can see is worth more than a claim that everything is accurate.
The Phase column sorts by where a catalyst sits in development rather than alphabetically: Phase 1 first, then 2, 3 and 4, with half-steps in their natural place (a Phase 1/2 readout between 1 and 2, a Phase 2b between 2 and 2/3), and regulatory events last — advisory committee meetings, then FDA decisions and PDUFA dates. Sorting the other way puts the latest-stage, nearest-to-market catalysts on top.
A PDUFA date is a day the FDA has committed to. A clinical readout almost never is — companies guide to "topline data in the first half of 2027" or "the fourth quarter of 2026", and that is the most precise thing anyone honestly has. Rows carry the timing at the precision the filing gave it, so a window shows as H1 2027 rather than a made-up day, and only exact dates get a countdown or a calendar entry. When sorting by date, a window sits behind every exact date in the last month it covers: Q1 at the end of March, H1 and Q2 at the end of June, Q3 at the end of September, and H2, Q4 or a whole year at the end of December. Dated events always come first. More on why windows are vague and how they narrow.
The filing scan runs weekly, and the results are reviewed by hand before anything is published. Dates change — the FDA extends reviews, companies resubmit — so the date you see is the date as last confirmed. Each row shows when it was last verified, and the footer of every page shows the most recent check across the whole dataset (currently 14 Sep 2026).
If a row is wrong, tell us and it gets fixed, with the source link updated to match. That is the whole point of publishing the sources. The editorial policy covers corrections and independence in full.
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