---
schema_version: "secwatch.filing_event.v1"
accession: "0001171843-25-003152"
form_type: "8-K"
ticker: "BCRX"
cik: "0000882796"
company_name: "BIOCRYST PHARMACEUTICALS INC"
filed_at: "2025-05-14T23:59:59+00:00"
generated_at: "2026-05-21T11:58:34.524277+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# FDA accepts NDA for ORLADEYO granules in HAE ages 2-11; priority review, PDUFA Sep 12, 2025

## Summary
- FDA accepted NDA for once-daily ORLADEYO oral granules for HAE patients aged 2-11; priority review granted with PDUFA target Sep 12, 2025.
- If approved, ORLADEYO would be first targeted oral prophylactic therapy for HAE under age 12.
- NDA based on positive interim APeX-P trial data showing well-tolerated, consistent safety, and reduced monthly attack rates.
- BioCryst also filed line extension with EMA; regulatory filings planned in Japan and Canada.
- ORLADEYO already approved in US for patients 12+ and commercially available in over 30 countries.

## SEC filing metadata
- accession: 0001171843-25-003152
- form_type: 8-K
- ticker: BCRX
- cik: 0000882796
- company_name: BIOCRYST PHARMACEUTICALS INC
- filed_at: 2025-05-14T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/882796/000117184325003152/0001171843-25-003152-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/882796/000117184325003152/f8k_051425.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001171843-25-003152
- JSON: https://secwatch.observer/filing/0001171843-25-003152.json
- Plain text: https://secwatch.observer/filing/0001171843-25-003152.txt

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