Biopharma SEC 8 K Event Stream: FDA Approvals, CRLs, PDUFA, Topline Data, Deals & Offerings

A clean event feed of pharma and biotech 8 K and 6 K filings from SEC EDGAR. Each filing's EX 99 press release is read and classified into an event type (FDA approval, complete response letter (CRL), PDUFA date, topline data, deal, offering or other), with the ticker, company, filing date and key number (PDUFA date, offering size, upfront payment, p value). Official SEC data, no login, no API key. Data and events only, not investment advice.

Event type	Examples	Key number
❌ crl	Complete response letter received	n/a
✅ approval	FDA / EC / MHRA approval, CHMP positive opinion	n/a
📅 pdufa	PDUFA target action date, NDA/BLA accepted, priority review, advisory committee	PDUFA / AdCom date
📈 topline	Topline results, primary endpoint met or missed	p value or effect size
🤝 deal	M&A, licensing, collaboration, royalty deals	Upfront, total value or price per share
💵 offering	Public offering, PIPE, registered direct, ATM, convertible notes	Gross proceeds / offering size
📄 other	Earnings, designations, clinical holds, leadership, listing notices, governance	n/a

What it does

• Lists every 8 K and 6 K in your date range from SEC EDGAR full text search
• Keeps filers with pharma and biotech SIC codes (2833, 2834, 2835, 2836, 8731 by default; medical devices optional)
• Opens each filing index, reads the attached EX 99 press releases and the filing itself
• Classifies the event (priority: CRL > approval > PDUFA > topline > deal > offering > other) and lists all event types it found
• Extracts the key number, a headline and the sentence that triggered the classification
• Gives you links to the filing index, the primary document and every EX 99 exhibit

Who uses it

• Biotech traders and analysts: a morning list of catalysts filed overnight, with ticker and key number.
• Newsletter writers and journalists: every approval, CRL, readout and deal from the official filings.
• Fintech and data teams: a structured biopharma event feed for alerts, dashboards and models.
• BD and competitive intelligence: licensing deals and upfront payments as they're filed.

Input

Field	Example	Notes
Days back	3	Or set Date from / Date to
Event types	["approval", "crl", "topline"]	Empty = all
Include 'other'	true	Earnings, governance, conferences…
Tickers	["GSK", "AZN"]	Empty = all biopharma filers
SIC codes	["2834", "2836", "8731"]
Add medical devices	false	Adds 3841, 3842, 3845, 8071
Forms	["8-K", "6-K"]
Max events	200	Newest filings first
Contact email	you@example.com	Optional: replaces the default contact in the SEC User Agent

Example: catalysts from the last 24 hours, no noise

{ "daysBack": 1, "eventTypes": ["crl", "approval", "pdufa", "topline", "deal", "offering"] }

Example: everything a watchlist filed this month

{ "dateFrom": "2026-10-01", "tickers": ["GSK", "AZN", "BNTX", "ARGX"] }

Output

{
  "ticker": "HCM",
  "company": "HUTCHMED (China) Ltd",
  "form": "6-K",
  "filedDate": "2026-10-21",
  "eventType": "deal",
  "eventSubtype": "licensing-collaboration",
  "allEventTypes": ["deal"],
  "keyNumber": "$110.0M",
  "keyNumberLabel": "Upfront payment",
  "headline": "HUTCHMED Announces Closing of KRAS-EGFR-Antibody Conjugate Therapy License to GSK Outside China",
  "snippet": "HUTCHMED Announces Closing of KRAS-EGFR-Antibody Conjugate Therapy License to GSK Outside China…",
  "filingIndexUrl": "https://www.sec.gov/Archives/edgar/data/1648257/000164825726000066/0001648257-26-000066-index.htm",
  "exhibits": [{ "type": "EX-99.1", "url": "https://www.sec.gov/Archives/edgar/data/1648257/…" }],
  "source": "SEC EDGAR",
  "disclaimer": "Data and events from public SEC filings only. Not investment advice."
}

Other fields: tickers, cik, items and itemDescriptions (8 K item codes), sic, keyNumberUnit, primaryDocumentUrl, accessionNumber, location. A RUN_SUMMARY record has the counts per event type and the number of SEC requests.

Cost

You pay one event per classified filing in the output. A daily run over all biopharma filers is typically 20 to 60 events. See the Pricing tab for current prices.

API

curl -X POST "https://api.apify.com/v2/acts/seaf999ield~biopharma-sec-event-stream/run-sync-get-dataset-items?token=YOUR_TOKEN" \
  -H "Content-Type: application/json" -d '{"daysBack":1,"eventTypes":["approval","crl","topline"]}'

Schedule it every weekday morning and send new events to Slack, Sheets or a webhook.

Is it legal?

Yes. SEC EDGAR filings are public US government records. The actor follows the SEC fair access policy: it declares a User Agent with contact details (the actor maintainer's contact email by default; set contactEmail to use your own), stays well under 10 requests per second (about 6), and only reads EDGAR full text search and the EDGAR Archives. It doesn't log in, bypass anything or use third party data.

FAQ

How accurate is the classification? It's rule based on the press release text and 8 K item codes, and tuned for precision on the main catalysts. Always check the linked filing. allEventTypes shows every event type mentioned, so an earnings release that mentions a PDUFA date is labelled financial-results but lists pdufa.

Why 8 K and 6 K? US issuers file press releases as 8 K exhibits (usually EX 99.1). Foreign private issuers such as GSK, AstraZeneca, BioNTech and argenx file them as 6 K.

How fresh is it? EDGAR publishes filings within minutes. Run it each morning with daysBack: 1.

Does it give buy or sell signals? No. It reports what companies filed. This is not investment advice.

Does it cover FDA calendars and openFDA too? Pair it with our Biotech Catalyst Tracker for openFDA approvals, CRLs, the AdCom calendar, MHRA and ClinicalTrials.gov.

More

• Weekly newsletter, UK Industry & Bills: https://ukindustryandbills.substack.com

Source: U.S. Securities and Exchange Commission, EDGAR. Data and events only. This is not investment advice.