Company Events & EarningsCore researchInvalidNew

Pdufa Label Type Drift

Updated dailyData needs: lowlong only

paper

2024

Source

Industry mechanism: PDUFA approval windows differ by label type (NME larger reprice than label expansion).

Read the paper →

In plain terms

FDA PDUFA approval dates for new drugs (vs label expansions) drive bigger price swings.

How it works

FDA PDUFA event window split by NME (first-time drug) vs label-expansion (repeat drug_name).

No live results for this strategy yet. Charts appear once it has earned a top spot on at least one stock, either on its own or as part of a blend of several strategies.

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Data dependencies

Fda adcomm
A data feed this strategy reads, refreshed on its normal schedule.
Daily prices
Adjusted-close OHLCV for every US-listed ticker; primary price feed.

Expected edge

Reported return: ~5-15% per event
Reported Sharpe: ~0.5
Tested over: T-15d to T+30d

PDUFA events drive ~5-15% reprice; NMEs cluster in upper range.

Example tickers where this is likely to fire

PFE REGN BMY LLY

Illustrative only, the signal fires based on the live data, not a fixed list.

Related families

Fda Adcomm PdufaCompany Events & Earnings

FDA AdComm + PDUFA target dates are ±15% binary catalysts.

Clinical Trial Enrollment VelocityCompany Events & Earnings

When a Phase III trial gets terminated or withdrawn, the sponsor's stock tends to drop over 1-3 months. Symmetric for completed-with-results.

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