---
schema_version: "secwatch.filing_event.v1"
accession: "0001171843-25-004091"
form_type: "8-K"
ticker: "BCRX"
cik: "0000882796"
company_name: "BIOCRYST PHARMACEUTICALS INC"
filed_at: "2025-06-25T23:59:59+00:00"
generated_at: "2026-05-18T21:47:15.284926+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# FDA extends PDUFA goal date for BioCryst's ORLADEYO pediatric NDA to Dec 12, 2025

## Summary
- FDA determined submission of additional final reports and formulation data is a major amendment, extending review by three months.
- New PDUFA target action date set for December 12, 2025, after original goal date extended.
- NDA seeks approval of once-daily ORLADEYO oral granules for HAE in pediatric patients aged 2 to 11 years.

## SEC filing metadata
- accession: 0001171843-25-004091
- form_type: 8-K
- ticker: BCRX
- cik: 0000882796
- company_name: BIOCRYST PHARMACEUTICALS INC
- filed_at: 2025-06-25T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/882796/000117184325004091/0001171843-25-004091-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/882796/000117184325004091/f8k_062525.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001171843-25-004091
- JSON: https://secwatch.observer/filing/0001171843-25-004091.json
- Plain text: https://secwatch.observer/filing/0001171843-25-004091.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.