Event / FDA#326tier 2experimental liveNew
pdufa extension short
cadence: Dailydata: mediumshort only
paper
2011
Source
Kaitin, K.I. & DiMasi, J.A. (2011). "Pharmaceutical innovation in the 21st century: New drug approvals in the first decade, 2000-2009." Drug Information Journal, 45(2-3), 175-186.
Read the paper →
What it checks
When the FDA pushes back a drug's review date by a month or more, we short the sponsor for the next few weeks.
Mechanism
FDA PDUFA action-letter delay (Complete Response Letter or 3-month extension) signals additional analyses/trials are required; sponsor stock reprices -3 to -5% event-day with -2% drift over 30d.
No production champion data for this family yet. Stats appear once the discovery pipeline promotes at least one strategy with this family tag, or once a multi-family blend that includes it earns a champion slot.
Signal rule
When fda_adcomm records a new (later) PDUFA action_date for the same (ticker, drug_name) with >=30d push-back -> SHORT sponsor T+1 (announcement = min(ingested_at, meeting_date - 30d)); hold 5/10/20 trading days.
Data dependencies
daily_pricesAdjusted-close OHLCV for every US-listed ticker; primary price feed.
fda_adcommWorker data table — see services/worker schema.
Expected edge
- Paper alpha
- -3 to -5% event-day, -2% over 30d
- Paper window
- T+1 to T+20d
Kaitin-DiMasi 2011: -3 to -5% event-day, -2% over 30d.
Example tickers where this is likely to fire
Illustrative only — the signal fires based on the live data, not a fixed list.
Related families
Explore pdufa extension short on alphactor.ai
See which tickers this family is currently firing on, with live signals and rankings.