# RareDiseaseHedge — State of Bio 2026

> A screen of drugs approved by a foreign regulator (EMA, EEA national registers via
> the EMA Article 57 database, Health Canada, Swissmedic, PMDA) whose active moiety has
> never been approved in the United States. That is the population the FD&C Act
> §529 makes eligible for a rare-pediatric Priority Review Voucher (PRV). Each
> candidate carries a machine-drafted §529 eligibility checklist plus PubMed,
> ClinicalTrials.gov, ChEMBL, Orphadata, EU orphan-designation and FDA complete-response
> signals. Automated agents and AI assistants are welcome to read every page here.

Data snapshot: UNII 4Aug2026 · Drugs@FDA 12 Oct 2026 · Orange Book 12 Oct 2026 · EMA 12 Oct 2026 · Health Canada 12 Oct 2026 · Swissmedic 12 Oct 2026 · PMDA 12 Oct 2026 · GSRS relationship graph
Generated: 2026-10-12

## Headline numbers
- Candidates (approved abroad, never in the US): 338
- Multi-regulator candidates: 22
- Dossier-only (unnamed) rows: 32; rows queued for human review: 9
- Foreign approval rows screened: 18107; of which already in the US record: 2027
- Disclosed PRV sales tracked (SEC 8-K): 36; 2026 range US$ 180.0M–210.0M; record US$ 350.0M (2015)
- Months until the rare-pediatric PRV programme sunset: 35

## Pages
- [Almanac (home)](https://rarediseasehedge.carterpry.com/): searchable shortlist, PRV market charts, pipeline breadth, approval map
- [Candidate table, static HTML](https://rarediseasehedge.carterpry.com/candidates): all candidates in one plain table, no JavaScript needed
- [Full candidate list, plain text](https://rarediseasehedge.carterpry.com/llms-full.txt): one section per candidate incl. the §529 checklist
- [Card-list dashboard](https://rarediseasehedge.carterpry.com/list/): interactive cards with notes export/import
- [Funnel report](https://rarediseasehedge.carterpry.com/funnel): how 18k foreign approval rows narrow to the shortlist
- [Accuracy audit](https://rarediseasehedge.carterpry.com/audit): harness results and known limitations
- [Raw pipeline output, JSON](https://rarediseasehedge.carterpry.com/data/summary.json): everything above, machine-readable

## Notes
- Charts labelled "RDH pipeline" and "SEC 8-K filings" are real data; charts labelled "Illustrative" (disease areas, modalities) are design placeholders.
- Nothing on this site is investment, legal, business or tax advice.