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Regulatory Catalysts

by io.github.pipeworx-io
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Pdufa Catalysts

pdufa_catalysts
Read-onlyIdempotent

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.

Input Schema

NameRequiredDescriptionDefault
limitNoNumber of disclosures to return (1–10). Default 8.
queryNoOptional 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.
sinceNoStart of the filing-date window (YYYY-MM-DD). Default: 120 days before today.
untilNoEnd of the filing-date window (YYYY-MM-DD). Default: today.

Schema Changelog

Changes observed during successful MCP inspections.

  1. Changed1 schema field changed
    • addedInput schema / examples
      Added value: +[
+  {},
+  {
+    "query": "Capricor"
+  },
+  {
+    "limit": 10
+  }
+]
  2. First observed

TDQS

A4.7/5.0
Behavior4/5

Does the description disclose side effects, auth requirements, rate limits, or destructive behavior?

Annotations already indicate read-only, idempotent, and non-destructive behavior. The description adds useful behavioral detail by noting it performs keyless searches of SEC EDGAR and extracts surrounding context, without contradicting any annotations.

Agents need to know what a tool does to the world before calling it. Descriptions should go beyond structured annotations to explain consequences.

Conciseness4/5

Is the description appropriately sized, front-loaded, and free of redundancy?

The description is front-loaded with the main purpose and contains mostly useful detail. It is somewhat long and includes promotional phrasing like 'highest-signal binary biotech catalyst,' but every substantive sentence contributes to understanding the tool's behavior and output.

Shorter descriptions cost fewer tokens and are easier for agents to parse. Every sentence should earn its place.

Completeness5/5

Given the tool's complexity, does the description cover enough for an agent to succeed on first attempt?

With no output schema, the description fully enumerates return fields: company, ticker, CIK, filing date, form, PDUFA date or period, context snippet, URL, and accession number. It also explains the date-versus-period distinction and the regulatory-review scope, making the tool usable without further documentation.

Complex tools with many parameters or behaviors need more documentation. Simple tools need less. This dimension scales expectations accordingly.

Parameters5/5

Does the description clarify parameter syntax, constraints, interactions, or defaults beyond what the schema provides?

All four parameters are documented in the schema. The description adds extra semantic value by explaining that since/until bound the filing_date window and that filing_date represents when a drug entered FDA review, directly supporting the 'what entered review last week' use case.

Input schemas describe structure but not intent. Descriptions should explain non-obvious parameter relationships and valid value ranges.

Purpose5/5

Does the description clearly state what the tool does and how it differs from similar tools?

Description clearly states the tool searches SEC EDGAR 8-K filings for disclosed PDUFA dates and extracts the date and surrounding context. It also explains the regulatory-status reading, which distinguishes it from clinical-trial tools and the fda_adcom_calendar sibling.

Agents choose between tools based on descriptions. A clear purpose with a specific verb and resource helps agents select the right tool.

Usage Guidelines5/5

Does the description explain when to use this tool, when not to, or what alternatives exist?

Provides explicit use cases: PDUFA dates, FDA review status, drugs under review, accepted submissions, and awaiting-approval catalysts. It also gives a clear when-not-to-use instruction, directing users to clinicaltrials tools for trial-related queries.

Agents often have multiple tools that could apply. Explicit usage guidance like "use X instead of Y when Z" prevents misuse.

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