---
schema_version: "secwatch.filing_event.v1"
accession: "0001171843-25-007909"
form_type: "8-K"
ticker: "BCRX"
cik: "0000882796"
company_name: "BIOCRYST PHARMACEUTICALS INC"
filed_at: "2025-12-12T23:59:59+00:00"
generated_at: "2026-05-16T13:26:29.099597+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# BioCryst gets FDA approval for ORLADEYO oral pellets for HAE patients aged 2 to <12 years

## Summary
- FDA approved ORLADEYO oral pellet formulation for prophylactic therapy in HAE children aged 2 to <12 years.
- First and only oral prophylactic treatment for this age group; previously only injectable options were available.
- Approval supported by APeX-P trial interim data showing early and sustained attack rate reductions with no new safety signals.
- BioCryst plans EU, Japan, and other regulatory filings; ORLADEYO capsule already approved for ages 12+ since Dec 2020.
- More than 3,500 patients in the US have been prescribed ORLADEYO to date.

## SEC filing metadata
- accession: 0001171843-25-007909
- form_type: 8-K
- ticker: BCRX
- cik: 0000882796
- company_name: BIOCRYST PHARMACEUTICALS INC
- filed_at: 2025-12-12T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/882796/000117184325007909/0001171843-25-007909-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/882796/000117184325007909/f8k_121225.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001171843-25-007909
- JSON: https://secwatch.observer/filing/0001171843-25-007909.json
- Plain text: https://secwatch.observer/filing/0001171843-25-007909.txt

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