---
name: FDA Catalyst Analysis
slug: fda-catalyst-analysis
category: Data
description: FDA Catalyst Analysis builds a dated catalyst calendar for biotech and pharma tickers, including PDUFA dates, AdComs, device decisions, trial readouts, and earnings. It also frames likely outcomes and highlights coverage gaps when data is missing.
github: "https://github.com/agentii-ai/agentii-investment-intelligence/tree/main/plugins/vertical-plugins/bio-pharm/skills/agentii/fda-catalyst-analysis"
language: Python
stars: 203
forks: 16
install: "npx degit https://github.com/agentii-ai/agentii-investment-intelligence/tree/main/plugins/vertical-plugins/bio-pharm/skills/agentii/fda-catalyst-analysis ~/.claude/skills/fda-catalyst-analysis"
installs_to: ~/.claude/skills/fda-catalyst-analysis
source_path: plugins/vertical-plugins/bio-pharm/skills/agentii/fda-catalyst-analysis/SKILL.md
collection_size: 21
category_size: 762
collection_url: "https://dirskills.com/collections/agentii-ai/agentii-investment-intelligence"
added: 2026-09-05T05:29:51.818Z
last_synced: 2026-09-05T05:29:51.818Z
canonical_url: "https://dirskills.com/skills/fda-catalyst-analysis"
---

# FDA Catalyst Analysis

FDA Catalyst Analysis builds a dated catalyst calendar for biotech and pharma tickers, including PDUFA dates, AdComs, device decisions, trial readouts, and earnings. It also frames likely outcomes and highlights coverage gaps when data is missing.

**Install:**

```bash
npx degit https://github.com/agentii-ai/agentii-investment-intelligence/tree/main/plugins/vertical-plugins/bio-pharm/skills/agentii/fda-catalyst-analysis ~/.claude/skills/fda-catalyst-analysis
```

## README

> Methodology inspired by publicly taught biotech catalyst frameworks; all text is an original paraphrase.

## Defaults

| Parameter | Default Value | Rationale |
|-----------|---------------|-----------|
| forward_window_quarters | 4 | Standard catalyst window; extend to 8 on request |
| include_superseded | false | Active-only events by default; supersede chains available on request |
| min_verification | false | Show all events; annotate unverified instead of hiding |
| horizon_days | 180 | Default for get_upcoming_pdufa horizon |
| domain | event-driven | Med catalyst analysis is event-driven by construction |

## Preflight

Run canonical pre-flight per `contracts/preflight.md`. Propagate X-Agentii-Trace per `contracts/x-agentii-trace-header.md`. Confirm ticker resolution via `search_companies` before catalyst queries.

## Triggers

- "What FDA catalysts are coming up for [ticker]?"
- "When is the PDUFA date for [drug/ticker]?"
- "Build a catalyst calendar for my biotech watchlist."
- "What AdCom meetings are scheduled for [ticker]?"
- "How does the market typically react to [approval/CRL/AdCom vote]?"
- "What are the binary events for [ticker] over the next 6 months?"
- "Which med names have FDA decisions this quarter?"
- "Evaluate the approval odds for [drug] ahead of its PDUFA."
- "What happened the last time a similar drug went to AdCom?"
- "List upcoming device decisions (PMA/De Novo/510(k)) for [ticker]."
- "Which catalysts overlap with [ticker]'s earnings date?"
- "Recap the decision history for [application/drug]."

## Production Grounding

- FDA decisions (approve/CRL/withdraw) are the strongest price catalysts in `med.medicines_biotech`; AdCom votes often pre-move the stock by days.
- Regulatory mechanics: PDUFA target dates, priority review, breakthrough designation, accelerated approval, CRL remediation timelines, AdCom vote patterns (approve/reject/deferral/conditional), post-marketing requirements.
- AdCom-style scrutiny axes to apply when framing outcome odds: safety signals, statistical adequacy, subgroup analyses, missing data, endpoint appropriateness, benefit-risk reasoning (per `references/knowledge-frameworks.md`).
- Devices: PMA / De Novo / 510(k) decisions carry similar binary-event dynamics (`get_device_decision`).
- Never fabricate dates, votes, or outcomes. When a tool returns nothing, annotate the coverage gap.

## Data Source Priority

1. Structured catalyst data: `get_upcoming_pdufa` / `get_pdufa_decision` / `get_device_decision` (pipeline.fda_calendar_event / device_decision_event).
2. Trial context: `search_clinical_trials` / `get_clinical_trial`; approval history: `search_fda_approvals` / `get_fda_approval`.
3. Company/filing context: `get_company_profile`, `search_documents`, `read_source_outline/pages` (incl. adcom briefing docs via meeting slugs).
4. Historical grounding: `search_investment_cases` (sectors=med, event_type=adcom_vote/pdufa_decision/crl/approval), `search_by_analogue`, `search_investment_strategies` (sectors=med).
5. Earnings overlap: `search_earnings_calendar` / `list_upcoming_earnings`.

## Methodology

### Retrieval Scope
unstructured_document_search

### Retrieval Strategy
1. Resolve ticker(s) via `search_companies`; collect company_id/cik for device queries.
2. Pull active catalyst events: `get_upcoming_pdufa` (ticker, horizon_days=default), `get_device_decision`, upcoming earnings.
3. For each major event, pull decision history (`get_pdufa_decision` by drug/application) and trial context (`search_clinical_trials`).
4. For AdCom events, retrieve the meeting documents via `list_sources(source_type=adcom_briefing)` + `read_source_outline/pages` using meeting slug citations; apply scrutiny axes.
5. Ground the play in knowledge: `search_investment_cases`/`search_by_analogue` with med filters; cite /v/ records.

### Temporal Scope
See frontmatter temporal_scope block. Historical decision history may span up to 8 quarters back when requested.

### Tool Allowlist
See frontmatter allowed_tools.

### Protocol
1. Ticker resolution
2. Catalyst enumeration (dated events)
3. Per-event outcome framing (scrutiny axes + decision history)
4. Historical analogue retrieval
5. Calendar synthesis + risk flags

## Modes

- **Watchlist** (default, multi-ticker): produce one calendar with per-ticker sections; sort by date.
- **Single ticker deep-dive**: full event timeline + per-event probability framing + positioning context.
- **Event type**: restrict to PDUFA / AdCom / devices / trials / earnings on request.

## Tool Fallbacks

| Failure | Fallback |
|---------|----------|
| get_upcoming_pdufa empty | Search filings (`search_documents` keyword PDUFA) + `search_sec_filings` 8-Ks; annotate coverage_gap |
| AdCom retrieval path 404 | `search_documents` with source_institution filter; degrade to calendar metadata |
| search_clinical_trials unavailable | Use filings/announcements; flag degraded |
| Knowledge tools empty | Proceed with structured data only; annotate knowledge coverage_gap |

## Output File

`{ticker}/{YYYY-MM-DD_HHMM}_fda-catalyst-analysis_{affix}.md` (watchlist: `watchlist/{YYYY-MM-DD_HHMM}_fda-catalyst-calendar_{affix}.md`)

## Output Structure

1. **Executive Summary** — highest-impact catalysts in the window, 2-3 sentences
2. **Catalyst Calendar** — dated table: date, ticker, event type, drug/device, application, expected-impact framing
3. **Per-Event Analysis** — scrutiny-axes assessment (safety/statistics/subgroups/benefit-risk) + decision history
4. **Historical Analogues** — matched cases with /v/ citations and quantified outcomes
5. **Risk Assessment** — binary-risk sizing, overlap clusters, low-verification flags
6. **Coverage Gaps** — missing data, degraded modes, unverified events

## Error Handling

| Error | Fallback |
|-------|----------|
| No PDUFA rows | Fall back to earnings + pipeline events; annotate `coverage_gap` — never fabricate dates |
| Superseded dates | Active-only by default; expose supersede chain via `include_superseded=true` |
| Ticker not in med universe | Resolve via CIK/drug-universe match; surface the classification gap |

## Memory Load

See `contracts/memory-load.md`.

## Snapshot

See `contracts/snapshot-synthesis.md`.

## Final Summary (TUI)

Include ### Key Citations block with 0-10 clickable /v/ URLs.

## References

- `contracts/citation-and-memory.md`
- `contracts/output-frontmatter-schema.md`
- `contracts/memory-load.md`
- `contracts/snapshot-synthesis.md`
- `contracts/preflight.md`
- `references/knowledge-frameworks.md`