PDUFA dates explained
The FDA's decision deadline — and the single biggest binary event for many biotechs.
A PDUFA date is the target deadline by which the FDA aims to decide on a drug application. It's named after the Prescription Drug User Fee Act, under which companies pay fees in exchange for a committed review timeline.
Why it moves stocks
It's a binary catalyst with three outcomes: approval, a Complete Response Letter (a CRL — effectively a rejection that lists what's needed), or a delay. For a small company whose value rests on one drug, the result can double the stock or cut it in half in a day.
Things to watch
- PDUFA dates can slip — the FDA may extend the review (often ~3 months) when new data is submitted.
- An Advisory Committee (AdComm) meeting often precedes the decision and is itself a catalyst.
- A CRL is not always fatal — but it usually means more trials or manufacturing fixes, i.e. more time and cash.
How we use it
PDUFA dates are the highest-value catalysts we track. Because no clean public API lists them, they're best extracted from company 8-Ks and press releases.
Educational only — not financial advice.