Event / FDA#327tier 2experimental liveNew

fast track designation long

cadence: Dailydata: mediumlong only
paper
2017
Source
Mostaghim, S.R., Gagne, J.J. & Kesselheim, A.S. (2017). "Safety related label changes for new drugs after approval in the US through expedited regulatory pathways: Retrospective cohort study." BMJ, 358:j3837.
Read the paper →

What it checks

When the FDA grants a Fast-Track or Priority Review designation, we go long the sponsor for the next 2-3 months.

Mechanism

FDA expedited-pathway designations (Fast-Track, Breakthrough Therapy, Priority Review) compress timeline and signal regulator's unmet-need view; sponsor stock reprices ~+5% on designation, +8% over 60d.

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

First (ticker, drug_name) appearance in fda_adcomm -> LONG sponsor T+1 (announcement = min(first_ingest, first_action_date - 180d)); hold 20/40/60 trading days.

Data dependencies

  • daily_prices

    Adjusted-close OHLCV for every US-listed ticker; primary price feed.

  • fda_adcomm

    Worker data table — see services/worker schema.

Expected edge

Paper alpha
+5% event-day, +8% over 60d
Paper window
T+1 to T+60d

Mostaghim-Gagne-Kesselheim 2017: +5% event-day, +8% over 60d.

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 fast track designation long on alphactor.ai

See which tickers this family is currently firing on, with live signals and rankings.

For informational and educational purposes only. Not financial advice. Learn more