# Biotech Catalyst Calendar - PDUFA Dates, Trial Readouts & FDA (`smartmoney-data/biotech-catalyst-calendar`) Actor

Biotech catalysts per ticker: Phase 2/3 trial readout dates from ClinicalTrials.gov, FDA approvals from openFDA and PDUFA / advisory committee dates from SEC 8-K press releases, in one dated calendar. No API keys.

- **URL**: https://apify.com/smartmoney-data/biotech-catalyst-calendar.md
- **Developed by:** [SmartMoney Data](https://apify.com/smartmoney-data) (community)
- **Categories:** Business, AI, Developer tools
- **Stats:** 3 total users, 2 monthly users, 100.0% runs succeeded, 0 bookmarks
- **User rating**: No ratings yet

## Pricing

$5.00 / 1,000 catalysts

This Actor is paid per event. You are not charged for the Apify platform usage, but only a fixed price for specific events.

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

## What's an Apify Actor?

An Actor is a serverless cloud program that runs on the Apify platform. It has two run modes.
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.

Apify vocabulary and the platform model are defined once, in the agent quickstart at https://apify.com/agents.md.

## 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.

Do not guess an integration path. Every one of them is in the agent quickstart at https://apify.com/agents.md: the Apify MCP server, Agent Skills with the Apify CLI, the JavaScript and Python clients, the REST API, and the account-free path for an agent with no human to sign in. It also carries the rule on stating cost before the first paid run.

For examples already wired to this Actor's own input schema, see the [API](#api) section below.

Each client library has reference documentation the quickstart does not restate: [JavaScript/TypeScript](https://docs.apify.com/api/client/js/docs.md) (`npm install apify-client`) and [Python](https://docs.apify.com/api/client/python/docs.md) (`pip install apify-client`).

# README

## Biotech Catalyst Calendar - PDUFA Dates, Trial Readouts & FDA

**Every dated catalyst for your biotech watchlist in one calendar: trial readouts, PDUFA dates, advisory committees and FDA approvals.**

| | |
|---|---|
| **Data** | ClinicalTrials.gov, openFDA (Drugs@FDA) and SEC 8-K press releases |
| **Price** | $5 per 1,000 catalysts, no subscription. Apify's free plan credit covers a first test. |
| **Freshness** | Latest registry and filing data on every run |
| **Try it** | The input is pre-filled with a working example: just click **Start**. |

**Example output**

| Ticker | Date | Event | Detail |
|---|---|---|---|
| XYZ | 2026-11-30 | PDUFA date | FDA decision on drug X for indication Y |
| ABC | 2027-01 (est.) | Phase 3 readout | Primary completion, 640 patients |

*Illustrative rows; real runs return the full fields listed under Output.*

Biotech stocks move on a handful of dates: when a pivotal trial reads out, when the FDA decides (the PDUFA date), when an advisory committee meets. This Actor builds that calendar from official sources, with no API keys:

- **ClinicalTrials.gov:** primary-completion dates of the company's own Phase 2/3 trials, the point after which topline data usually follows.
- **SEC 8-K filings:** PDUFA target action dates and advisory committee dates the company announced in its press releases, with the sentence they came from.
- **openFDA (Drugs@FDA):** recent FDA approvals of the company's applications.

### What you can do with it

- 📅 **Event-driven trading:** know which names have a binary event in the next 30, 90 or 365 days.
- 💊 **Options research:** line up implied volatility against the PDUFA date.
- 🔔 **Weekly digest:** schedule it and send the coming catalysts to Slack, Sheets or email.
- 🧪 **Pipeline tracking:** every late-stage trial a company runs, with phase, enrollment and status.

### How to use it

#### Your watchlist, next 12 months

```json
{ "tickers": ["VRTX", "SRPT", "MRNA"] }
```

#### Only PDUFA and advisory committee dates, next 6 months

```json
{ "tickers": ["SRPT", "AXSM"], "sources": ["filings"], "daysAhead": 180, "daysBack": 0 }
```

#### Big pharma with a subsidiary as trial sponsor

```json
{ "tickers": ["LLY"], "extraNames": ["LLY=Loxo Oncology"], "phases": ["PHASE3"] }
```

### Output

One row per catalyst, sorted by date:

```json
{
  "ticker": "VRTX",
  "companyName": "VERTEX PHARMACEUTICALS INC / MA",
  "daysUntil": 112,
  "eventType": "pdufa-date",
  "date": "2027-01-30",
  "precision": "day",
  "isEstimated": false,
  "title": "PDUFA target action date",
  "detail": "The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of January 30, 2027.",
  "announcedOn": "2026-10-02",
  "mentions": 2,
  "source": "sec-8k",
  "url": "https://www.sec.gov/Archives/edgar/data/875320/..."
}
```

| eventType | Source | Notes |
|---|---|---|
| `trial-primary-completion` | ClinicalTrials.gov | `nctId`, `phase`, `trialStatus`, `enrollment`, `conditions`, `interventions`. `isEstimated: true` for planned dates; `precision: "month"` when the sponsor gave only a month. |
| `pdufa-date` | SEC 8-K | The announcing sentence is in `detail`; `mentions` counts filings repeating it. |
| `fda-advisory-committee` | SEC 8-K | As above. |
| `fda-approval`, `fda-supplement-approval` | openFDA | `product`, `activeIngredients`, `applicationNumber`. |

The **`SUMMARY`** record gives each ticker's next catalyst and lists any source that failed.

### Use it from code or an AI agent

**Python**

```python
from apify_client import ApifyClient

client = ApifyClient("<YOUR_APIFY_TOKEN>")
run = client.actor("smartmoney-data/biotech-catalyst-calendar").call(run_input={"tickers": ["VRTX", "SRPT", "MRNA"]})
for item in client.dataset(run["defaultDatasetId"]).iterate_items():
    print(item)
```

**AI agents (Claude, ChatGPT, Cursor and other MCP clients):** connect the Apify MCP server with this Actor preloaded:

```text
https://mcp.apify.com/?tools=smartmoney-data/biotech-catalyst-calendar
```

Add this URL as a remote MCP server or custom connector in your AI client, sign in with Apify (OAuth), then just ask, for example:

> What binary events do VRTX, SRPT and MRNA have in the next 90 days?

> Part of the **SmartMoney Data** suite: [Insider Trades](https://apify.com/smartmoney-data/sec-insider-trades-tracker) · [8-K Material Events](https://apify.com/smartmoney-data/sec-8k-material-events) · [Trading Halts](https://apify.com/smartmoney-data/trading-halts-suspensions-monitor) · [Short Squeeze Radar](https://apify.com/smartmoney-data/short-squeeze-radar) · [Smart Money Confluence](https://apify.com/smartmoney-data/smart-money-confluence-score) · [FDA Recall Checker](https://apify.com/smartmoney-data/openfda)

### Pricing

**Pay per result:** you're charged for each catalyst returned. See the **Pricing** tab for current rates.

### FAQ

**Are trial dates exact?**
They are what the sponsor registered on ClinicalTrials.gov. Planned dates move; `isEstimated` tells you which are planned and which already happened. Data usually follows a primary completion by weeks to a few months.

**Why is a PDUFA date missing?**
Companies are not required to disclose PDUFA dates, and some only mention them on earnings calls. This Actor finds the ones written in 8-K filings and their press-release exhibits.

**Does it cover big pharma?**
Yes, but large sponsors run hundreds of trials; use `phases` and `maxTrialsPerTicker` to focus.

### Support

**Useful?** A short review on this page helps other people find it, and we read every one.

Found a bug or need a feature? Open an issue on the **Issues** tab or email **smartmoney-data@googlegroups.com**.

*Data is provided for informational purposes only and is not investment advice.*

# Actor input Schema

## `tickers` (type: `array`):

Biotech or pharma tickers listed with the SEC, e.g. VRTX, MRNA, SRPT.

## `daysAhead` (type: `integer`):

How far into the future to look.

## `daysBack` (type: `integer`):

Also include recent events (approvals, completed trials) from this many days ago. 0 = upcoming only.

## `sources` (type: `array`):

Which catalyst sources to read.

## `phases` (type: `array`):

Only trials in these phases. Leave empty for all.

## `extraNames` (type: `array`):

TICKER=Name for subsidiaries or brand names used as trial sponsor, e.g. LLY=Loxo Oncology.

## `maxTrialsPerTicker` (type: `integer`):

Large pharma sponsor thousands of studies.

## `filingsLookbackDays` (type: `integer`):

How far back to read 8-K press releases for announced PDUFA and advisory committee dates.

## `maxFilingsPerTicker` (type: `integer`):

Newest first.

## `openFdaApiKey` (type: `string`):

Not needed at normal volume. A free key from open.fda.gov raises the rate limit.

## `secUserAgent` (type: `string`):

The SEC asks automated clients to identify themselves as 'Company Name email@domain.com'.

## Actor input object example

```json
{
  "tickers": [
    "VRTX",
    "SRPT"
  ],
  "daysAhead": 365,
  "daysBack": 30,
  "sources": [
    "trials",
    "fda",
    "filings"
  ],
  "phases": [
    "PHASE2",
    "PHASE3"
  ],
  "extraNames": [],
  "maxTrialsPerTicker": 300,
  "filingsLookbackDays": 365,
  "maxFilingsPerTicker": 40,
  "secUserAgent": "SmartMoney Data Biotech Catalysts smartmoney-data@googlegroups.com"
}
```

# Actor output Schema

## `results` (type: `string`):

No description

## `summary` (type: `string`):

No description

# 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 = {
    "tickers": [
        "VRTX",
        "SRPT"
    ]
};

// Run the Actor and wait for it to finish
const run = await client.actor("smartmoney-data/biotech-catalyst-calendar").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 = { "tickers": [
        "VRTX",
        "SRPT",
    ] }

# Run the Actor and wait for it to finish
run = client.actor("smartmoney-data/biotech-catalyst-calendar").call(run_input=run_input)

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

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

```

## CLI example

```bash
echo '{
  "tickers": [
    "VRTX",
    "SRPT"
  ]
}' |
apify call smartmoney-data/biotech-catalyst-calendar --silent --output-dataset

```

## MCP server setup

```json
{
    "mcpServers": {
        "apify": {
            "type": "http",
            "url": "https://mcp.apify.com/?tools=fetch-actor-details,smartmoney-data/biotech-catalyst-calendar"
        }
    }
}
```

The hosted server signs you in with OAuth on first connect, so no API token belongs in this config. Clients without OAuth support can send an `Authorization: Bearer <APIFY_API_TOKEN>` header instead, using a token from API & Integrations in Apify Console (https://console.apify.com/settings/integrations).

## OpenAPI specification

Download the OpenAPI definition: https://api.apify.com/v2/actors/FrQ8HUqmP5NmN0Ocf/builds/aMHZEkXcjZ2cUMIxu/openapi.json