# FDA Catalyst Alerts (`constant_quadruped/fda-catalyst-alerts`) Actor

Monitor FDA catalysts for biotech trading signals. Track PDUFA dates, Phase 3 completions, AdCom meetings, safety signals, and recalls. Get alerts via webhook when catalysts approach. Includes 100+ pharma ticker mappings. Schedule daily for continuous portfolio monitoring.

- **URL**: https://apify.com/constant\_quadruped/fda-catalyst-alerts.md
- **Developed by:** [CQ](https://apify.com/constant_quadruped) (community)
- **Categories:** News, Automation
- **Stats:** 5 total users, 3 monthly users, 83.6% runs succeeded, 1 bookmarks
- **User rating**: No ratings yet

## Pricing

Pay per usage

This Actor is paid per platform usage. The Actor is free to use, and you only pay for the Apify platform usage, which gets cheaper the higher subscription plan you have.

Learn more: https://docs.apify.com/platform/actors/running/actors-in-store#pay-per-usage

## What's an Apify Actor?

Actors are web data automations that power AI and operations. They run on the Apify platform to scrape websites, process data, connect APIs, and automate workflows.
In Batch mode, an Actor accepts a well-defined JSON input, performs an action which can take anything from a few seconds to a few hours,
and optionally produces a well-defined JSON output, datasets with results, or files in key-value store.
In Standby mode, an Actor provides a web server which can be used as a website, API, or an MCP server.
Actors are written with capital "A".

## How to integrate an Actor?

If asked about integration, you help developers integrate Actors into their projects.
You adapt to their stack and deliver integrations that are safe, well-documented, and production-ready.
The best way to integrate Actors is as follows.

- **AI agents and MCP clients** — the [Apify MCP server](https://docs.apify.com/integrations/mcp.md) at `https://mcp.apify.com` (remote, streamable HTTP, OAuth on first use).
- **Agentic workflows and local Actor development** — [Agent Skills](https://apify.com/.well-known/agent-skills/index.json) with the [Apify CLI](https://docs.apify.com/cli/docs.md): `npm install -g apify-cli`, then `apify login`.
- **JavaScript/TypeScript projects** — the official [JS/TS client](https://docs.apify.com/api/client/js/docs.md): `npm install apify-client`.
- **Python projects** — the official [Python client](https://docs.apify.com/api/client/python/docs.md): `pip install apify-client`.
- **Any other language** — the [REST API](https://docs.apify.com/api/v2.md).

For usage examples, see the [API](#api) section below.

For more details, see Apify documentation as [Markdown index](https://docs.apify.com/llms.txt) and [Markdown full-text](https://docs.apify.com/llms-full.txt).

# README

## 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**: Maps drug and sponsor names to stock tickers using a built-in curated list (~50 pharma/biotech name mappings)

### 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

```json
{
  "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. Only `CRITICAL` and `HIGH` severity alerts are delivered to the webhook; every catalyst and alert is still saved to the dataset regardless of severity.

#### Slack Format

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

#### Discord Format

```json
{
  "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 | `["PDUFA_DATE", "PHASE3_COMPLETION", "SAFETY_SIGNAL", "RECALL"]` | Which catalyst types to check (also supports `PHASE3_RESULTS`, `APPROVAL`, `CRL`) |
| `safetySignalThreshold` | number | `100` | Minimum adverse events in the last 90 days to trigger a safety signal |
| `includeAdverseEventSummary` | boolean | `true` | Must be enabled for `SAFETY_SIGNAL` checks to run |
| `webhookUrl` | string | - | Webhook URL for alerts (only CRITICAL/HIGH alerts are sent) |
| `webhookFormat` | string | `"generic"` | Format: `"slack"`, `"discord"`, or `"generic"` |
| `openfdaApiKey` | string | - | Optional free openFDA API key for higher daily rate limits |

### 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 a curated list of major pharma/biotech companies (~50 sponsor and drug name mappings). 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`

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

#### `PREVIOUS_STATE`

Used for tracking state between scheduled runs:

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

### Limitations

- **Not financial advice.** Output is informational only and must not be treated as investment, trading, or medical advice. Past performance of catalyst-based strategies does not guarantee future results.
- **Depends on external sources.** Data comes from ClinicalTrials.gov, openFDA (FAERS and Enforcement), the RTTNews FDA calendar, and FDA press releases. If any of these changes its layout, rate-limits requests, or goes down, the corresponding catalyst type may return no results for that run.
- **Watchlist-driven matching.** Catalysts are only surfaced for the drug/company names you provide. Matching is name-based (case-insensitive substring), so misspellings or uncommon brand/generic names may be missed.
- **Ticker coverage is limited.** Auto-resolution uses a built-in curated list (~50 mappings). Unrecognized names return no ticker unless supplied via `watchlistTickers`.
- **Safety signals use spontaneous reports.** Adverse event counts come from FAERS spontaneous reporting and are not adjusted for exposure or verified for causation.
- **PDUFA and decision scraping is best-effort.** The RTTNews calendar and FDA press-release pages are HTML-scraped and may return partial or empty results if their markup changes.
- **AdCom meetings are not included.** The FDA advisory-committee calendar is JavaScript-rendered and is not scraped by this actor.
- **Placeholder inputs.** `includeTrialData`, `emailAlerts`, and `previousRunDatasetId` (change detection) appear in the input schema but are not yet wired into the run logic and currently have no effect.
- **Possible empty dataset.** When nothing matches (or all sources are unavailable), the run completes successfully and writes a single `status` record rather than failing.

### Pricing

Priced via the Apify platform using compute units. Actual cost depends on your watchlist size, the number of catalyst types selected, and the built-in rate-limit delays between API calls — larger watchlists run longer and cost more.

***

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

# Actor input Schema

## `watchlist` (type: `array`):

List of drugs or companies to monitor. Enter brand names, generic names, or sponsor names.

## `watchlistTickers` (type: `array`):

Corresponding stock tickers for watchlist items. Same order as watchlist. Leave empty for auto-detection.

## `alertDaysBefore` (type: `array`):

Trigger alerts this many days before a catalyst (e.g., 30, 14, 7 days before PDUFA)

## `catalystTypes` (type: `array`):

Select which catalyst types to track

## `safetySignalThreshold` (type: `integer`):

Minimum number of new adverse events to trigger a safety signal alert

## `includeTrialData` (type: `boolean`):

Include detailed clinical trial data in alerts

## `includeAdverseEventSummary` (type: `boolean`):

Include adverse event statistics in output

## `webhookUrl` (type: `string`):

URL to send alerts to (Slack, Discord, Zapier, custom endpoint)

## `webhookFormat` (type: `string`):

Format for webhook payload

## `emailAlerts` (type: `string`):

Email address for alerts (uses Apify email integration)

## `previousRunDatasetId` (type: `string`):

Dataset ID from previous run for change detection. Leave empty for first run.

## `openfdaApiKey` (type: `string`):

Optional: Free API key from open.fda.gov for higher rate limits

## Actor input object example

```json
{
  "watchlist": [
    "Keytruda",
    "Humira",
    "Opdivo"
  ],
  "watchlistTickers": [
    "MRK",
    "ABBV",
    "BMY"
  ],
  "alertDaysBefore": [
    30,
    14,
    7,
    1
  ],
  "catalystTypes": [
    "PDUFA_DATE",
    "PHASE3_COMPLETION",
    "SAFETY_SIGNAL",
    "RECALL"
  ],
  "safetySignalThreshold": 100,
  "includeTrialData": true,
  "includeAdverseEventSummary": true,
  "webhookFormat": "generic"
}
```

# Actor output Schema

## `alerts` (type: `string`):

High-priority catalyst alerts requiring attention

## `catalysts` (type: `string`):

Complete calendar of upcoming FDA catalysts

# API

You can run this Actor programmatically using our API. Below are code examples in JavaScript, Python, and CLI, as well as the OpenAPI specification and MCP server setup.

## JavaScript example

```javascript
import { ApifyClient } from 'apify-client';

// Initialize the ApifyClient with your Apify API token
// Replace the '<YOUR_API_TOKEN>' with your token
const client = new ApifyClient({
    token: '<YOUR_API_TOKEN>',
});

// Prepare Actor input
const input = {
    "watchlist": [
        "Keytruda",
        "Humira",
        "Opdivo"
    ],
    "watchlistTickers": [
        "MRK",
        "ABBV",
        "BMY"
    ]
};

// Run the Actor and wait for it to finish
const run = await client.actor("constant_quadruped/fda-catalyst-alerts").call(input);

// Fetch and print Actor results from the run's dataset (if any)
console.log('Results from dataset');
console.log(`💾 Check your data here: https://console.apify.com/storage/datasets/${run.defaultDatasetId}`);
const { items } = await client.dataset(run.defaultDatasetId).listItems();
items.forEach((item) => {
    console.dir(item);
});

// 📚 Want to learn more 📖? Go to → https://docs.apify.com/api/client/js/docs

```

## Python example

```python
from apify_client import ApifyClient

# Initialize the ApifyClient with your Apify API token
# Replace '<YOUR_API_TOKEN>' with your token.
client = ApifyClient("<YOUR_API_TOKEN>")

# Prepare the Actor input
run_input = {
    "watchlist": [
        "Keytruda",
        "Humira",
        "Opdivo",
    ],
    "watchlistTickers": [
        "MRK",
        "ABBV",
        "BMY",
    ],
}

# Run the Actor and wait for it to finish
run = client.actor("constant_quadruped/fda-catalyst-alerts").call(run_input=run_input)

# Fetch and print Actor results from the run's dataset (if there are any)
print("💾 Check your data here: https://console.apify.com/storage/datasets/" + run["defaultDatasetId"])
for item in client.dataset(run["defaultDatasetId"]).iterate_items():
    print(item)

# 📚 Want to learn more 📖? Go to → https://docs.apify.com/api/client/python/docs/quick-start

```

## CLI example

```bash
echo '{
  "watchlist": [
    "Keytruda",
    "Humira",
    "Opdivo"
  ],
  "watchlistTickers": [
    "MRK",
    "ABBV",
    "BMY"
  ]
}' |
apify call constant_quadruped/fda-catalyst-alerts --silent --output-dataset

```

## MCP server setup

```json
{
    "mcpServers": {
        "apify": {
            "command": "npx",
            "args": [
                "mcp-remote",
                "https://mcp.apify.com/?tools=constant_quadruped/fda-catalyst-alerts",
                "--header",
                "Authorization: Bearer <YOUR_API_TOKEN>"
            ]
        }
    }
}

```

## OpenAPI specification

Download the OpenAPI definition: https://api.apify.com/v2/actors/qVUzP8gff9EtTOFKe/builds/fyuGIxYhfTVC6d17t/openapi.json