FDA Catalyst Alerts

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

Type	Description	Source
PDUFA_DATE	Upcoming FDA decision date	RTTNews FDA Calendar
PHASE3_COMPLETION	Phase 3 trial completing	ClinicalTrials.gov
PHASE3_RESULTS	Phase 3 results posted	ClinicalTrials.gov
SAFETY_SIGNAL	Adverse event spike detected	openFDA FAERS
RECALL	FDA recall announced	openFDA Enforcement
APPROVAL	FDA approval announced	FDA Press Releases
CRL	Complete Response Letter issued	FDA Press Releases

Alert Severity

Severity	Meaning
CRITICAL	Event happened or Class I recall
HIGH	Event within 7 days
MEDIUM	Event within 14 days
LOW	Event beyond 14 days

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

Parameter	Type	Default	Description
watchlist	array	[]	Drug names to monitor
watchlistTickers	array	[]	Stock tickers (optional, auto-resolved if not provided)
alertDaysBefore	array	[30, 14, 7, 1]	Days before event to trigger alerts
catalystTypes	array	all types	Which catalyst types to check
safetySignalThreshold	number	100	Minimum adverse events in 90 days to trigger safety signal
webhookUrl	string	-	Webhook URL for alerts
webhookFormat	string	"generic"	Format: "slack", "discord", or "generic"
openfdaApiKey	string	-	Optional openFDA API key for higher rate limits (240 vs 40 req/min)

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.

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