`pdufa_catalysts`

Pack: regulatory-catalysts · Endpoint: https://gateway.pipeworx.io/regulatory-catalysts/mcp

Companies with disclosed PDUFA dates — the highest-signal binary biotech catalyst. Searches recent SEC EDGAR 8-K filings (keyless) for PDUFA target / goal / action dates and extracts the date and surrounding context. A PDUFA date is the FDA decision date for an NDA or BLA; it is a scheduled binary event that moves biotech stocks. Returns each disclosure with company, ticker, CIK, filing date, form, PDUFA date (ISO when the filing gives a specific day), pdufa_period when the filing discloses only a coarser grain such as “Q1 2027” or “March 2027”, a short context snippet, the SEC filing URL, and accession number. A row may carry a period without a date — that is the filing being vague, not a lookup failure. Use for PDUFA date, PDUFA goal date, FDA decision date, upcoming FDA decisions, drug approval catalyst, NDA/BLA decision date, biotech binary event, catalyst by ticker. ALSO the REGULATORY-STATUS reading of the same data, which is what most callers actually ask: which drugs are currently UNDER FDA REVIEW, which medicines ENTERED FDA REVIEW or were ACCEPTED FOR REVIEW recently, new NDA/BLA SUBMISSIONS and FILINGS ACCEPTED by the FDA, drugs AWAITING FDA APPROVAL, what is in the FDA review queue. A company announces acceptance in an 8-K at the moment review begins, so filing_date is when the drug ENTERED review and pdufa_date is when the decision is due — bounding filing_date with since/until answers “what entered FDA review last week”. Note this is REGULATORY review of a marketing application, not clinical trials: for drugs entering or moving through TRIALS use the clinicaltrials tools instead.

Parameters

Name	Type	Required	Description
`query`	string	no	Optional extra term ANDed into the search — a drug or company name, e.g. “obecabtagene” or “Capricor”. Omit to search all PDUFA disclosures in the window.
`since`	string	no	Start of the filing-date window (YYYY-MM-DD). Default: 120 days before today.
`until`	string	no	End of the filing-date window (YYYY-MM-DD). Default: today.
`limit`	number,string	no	Number of disclosures to return (1–10). Default 8.

Example call

Arguments

{}

curl

curl -X POST https://gateway.pipeworx.io/regulatory-catalysts/mcp \
  -H 'Content-Type: application/json' \
  -d '{"jsonrpc":"2.0","id":1,"method":"tools/call","params":{"name":"pdufa_catalysts","arguments":{}}}'

TypeScript (@pipeworx/sdk)

import { Pipeworx } from '@pipeworx/sdk';
const pipeworx = new Pipeworx();

const result = await pipeworx.call('pdufa_catalysts', {});

More examples

{
  "query": "Capricor"
}

{
  "limit": 10
}

Connect

Add this to your MCP client config, or use one-click install buttons:

{
  "mcpServers": {
    "regulatory-catalysts": {
      "url": "https://gateway.pipeworx.io/regulatory-catalysts/mcp"
    }
  }
}

See Getting Started for client-specific install steps.

pdufa_catalysts