FDA Catalyst Alerts

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Monitor FDA catalysts for biotech trading signals. Track PDUFA dates, Phase 3 completions, safety signals, recalls, and FDA decisions. Get alerts via webhook when catalysts are approaching.

What This Actor Does

• PDUFA Date Tracking: Scrapes upcoming FDA decision dates from RTTNews FDA Calendar
• Phase 3 Trial Monitoring: Alerts when Phase 3 trials complete or approach completion dates
• Safety Signal Detection: Detects spikes in adverse event reports (FAERS)
• Recall Monitoring: Tracks FDA drug and device recalls
• FDA Decision Tracking: Monitors recent approvals and CRLs from FDA press releases
• Ticker Mapping: Automatically maps drug names to stock tickers (60+ pharma/biotech companies)

Use Cases

• Biotech Traders: Get ahead of market-moving FDA events
• Portfolio Managers: Monitor drug pipelines in your holdings
• Risk Management: Detect safety signals before they impact stock price
• Event-Driven Strategies: Track binary catalyst events

Example Input

{
"watchlist":["Keytruda","Humira","Opdivo","Dupixent"],
"watchlistTickers":["MRK","ABBV","BMY","REGN"],
"alertDaysBefore":[30,14,7,1],
"catalystTypes":["PDUFA_DATE","PHASE3_COMPLETION","PHASE3_RESULTS","SAFETY_SIGNAL","RECALL","APPROVAL","CRL"],
"safetySignalThreshold":100,
"webhookUrl":"https://hooks.slack.com/services/xxx",
"webhookFormat":"slack",
"openfdaApiKey":"your-openfda-api-key"
}

Catalyst Types

Alert Severity

Webhook Integration

Supports Slack, Discord, or generic webhooks.

Slack Format

{
"webhookUrl":"https://hooks.slack.com/services/...",
"webhookFormat":"slack"
}

Discord Format

{
"webhookUrl":"https://discord.com/api/webhooks/...",
"webhookFormat":"discord"
}

Scheduling

For continuous monitoring, schedule this actor to run daily:

• Every morning before market open (8 AM ET)
• Use Apify's built-in scheduler

Input Parameters

Data Sources

• RTTNews FDA Calendar: PDUFA dates and FDA decision calendar
• ClinicalTrials.gov: Phase 3 trial data
• openFDA FAERS: Adverse event reports
• openFDA Enforcement: Drug/device recalls
• FDA Press Releases: Approval announcements

Ticker Mapping

The actor includes mappings for 60+ major pharma/biotech companies. If your watchlist item isn't recognized, provide the ticker manually in watchlistTickers.

Key-Value Store Schema

The actor stores the following data in the key-value store:

RUN_STATS

{
"watchlistCount":4,
"catalystsFound":12,
"alertsTriggered":5,
"pdfuaDates":3,
"phase3Completions":4,
"safetySignals":2,
"recalls":3
}

PREVIOUS_STATE

Used for tracking state between scheduled runs:

{
"runDate":"2024-01-15T08:00:00.000Z",
"catalystCount":12,
"alertCount":5,
"watchlist":["Keytruda","Humira","Opdivo","Dupixent"]
}

Limitations

• PDUFA calendar data depends on RTTNews availability
• AdCom meeting data is NOT currently available (FDA.gov uses JavaScript-loaded content)
• Safety signals are based on spontaneous reporting (not clinical trials)
• Past performance of catalyst-based strategies does not guarantee future results

Pricing

Standard Apify compute units. Typical run: ~0.15 CU for a 10-drug watchlist.

Built by JCD | Data from ClinicalTrials.gov, openFDA, FDA.gov & RTTNews