secwatch.observer — SEC 8-K summary
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Issuer:     BIOCRYST PHARMACEUTICALS INC (BCRX)
CIK:        0000882796
Form:       8-K
Filed at:   2025-05-14T23:59:59+00:00
Accession:  0001171843-25-003152
Event type: regulatory
Sentiment:  positive
Materiality: 0.70
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/882796/000117184325003152/0001171843-25-003152-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/882796/000117184325003152/f8k_051425.htm
  HTML page:      https://secwatch.observer/filing/0001171843-25-003152

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer