Biotech trades one calendar: the PDUFA date, the day the FDA is due to decide. Calendar sites list the dates. Nobody keeps the record — what the stock did into the date, what the FDA decided, and what the stock did after. This ledger seals every decision date the day a company first files it on EDGAR, grades it forward against SPY from the undisturbed close before the date, and records the outcome only from a strict later filing. The calendar of dates still ahead is the product; the graded record is its credibility.
Every decision date still ahead, sealed the day the company filed it — nearest first. Disclosed is the filing that named the date; the product beside it is best-effort text extraction and is labelled with its confidence.
| Decision date | Company | Product | Disclosed | Company's record | Receipt |
|---|---|---|---|---|---|
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The product for a desk: for each outcome, how many decisions, the median run-up into the date, the median reaction, and SPY-relative excess at each horizon. A row carries a label only past 10 priced decisions. Positive excess = the stock beat SPY after the date.
| Outcome | Decisions | Priced | Run-up (30d) | Reaction | 1 mo | 3 mo | 6 mo | 12 mo |
|---|---|---|---|---|---|---|---|---|
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Decided inside the last year, horizons still accruing — newest first.
| Company | Product | Date | Outcome | Run-up | Undisturbed | Reaction | Since | vs SPY |
|---|---|---|---|---|---|---|---|---|
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Companies ranked by dates ahead, then decisions. A company is labelled only past 2 known outcomes: clean sheet, mixed, or CRL history. Click a company for its full history.
| Company | Ahead | Decided | Approved | CRL | Unknown | Median reaction | Record |
|---|---|---|---|---|---|---|---|
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Every decided date with a tape — run-up, undisturbed entry, reaction, SPY-relative excess at each horizon, the outcome and its receipt. Public at every tier.
| Company | Product | Date | Outcome | Run-up | Reaction | 1 mo | 3 mo | 12 mo | Receipts |
|---|---|---|---|---|---|---|---|---|---|
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A date is admitted only when a company's own 8-K names it in the same clause as the PDUFA token. The first filing to name a company-and-date pair seals it, and that filing is the receipt. Extensions create a new row for the new date; the old date stays, marked.
Entry is the close before the decision date. The run-up is the move from thirty calendar days before into that close; the reaction is the two-session move after it, because decisions often land after the close on the date itself.
Every horizon subtracts SPY between exactly the same closes. Returns are split-adjusted; a horizon grades only when a session sits within tolerance of the target date; a tape that ended grades at its last print, marked.
Approved or Complete Response Letter comes from a later 8-K in a window around the date, on strict phrases. Where no such filing exists the outcome is unknown and stays so. It is never inferred from the price.
Base rates carry a label past ten priced decisions; a company past two known outcomes. Everything before that is shown as accruing, never asserted.
Issuers with no ticker in EDGAR's index — often delisted since — are counted and shown, never dropped. They bias the base rates toward the companies that survived, and the page says so.
QL PDUFA Ledger is diagnostic research about public filings and prices, not investment advice and not a prediction of any regulatory decision. Dates and outcomes link their EDGAR filings; product names are best-effort text extraction; returns are arithmetic on split-adjusted closes; SPY is the benchmark. Past base rates do not determine future decisions.
A public, forward-graded record of FDA decision (PDUFA) dates. Every date a listed drug developer names in an 8-K is sealed the day it is first filed, with the filing as the receipt. When the date passes, the stock is graded from the undisturbed close before it — the 30-day run-up, the two-session reaction, and SPY-relative excess at 1, 3, 6 and 12 months — and the outcome is recorded from a strict later filing: approved, a Complete Response Letter, or no outcome filing found.
From the company's own later 8-K, filed within 21 days before to 60 days after the date, whose text says the FDA approved or granted approval, or names a Complete Response Letter. A passing mention of approval in an earnings release does not qualify. Where no such filing exists the outcome stays unknown — it is never inferred from the price move.
Everything that makes the record credible: base rates by outcome, the run-up and reaction distributions, every graded decision with its EDGAR receipt, company histories and the full methodology. The sealed calendar of decision dates still ahead is the Institutional product; lower tiers see the nearest few dates and identity-only rows for the rest.