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

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

Only PDUFA and advisory committee dates, next 6 months

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

Big pharma with a subsidiary as trial sponsor

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

Output

One row per catalyst, sorted by date:

{
  "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

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:

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 · 8-K Material Events · Trading Halts · Short Squeeze Radar · Smart Money Confluence · FDA Recall Checker

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.