secwatch.observer — SEC 8-K summary
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Issuer:     BIOCRYST PHARMACEUTICALS INC (BCRX)
CIK:        0000882796
Form:       8-K
Filed at:   2025-06-25T23:59:59+00:00
Accession:  0001171843-25-004091
Event type: regulatory
Sentiment:  negative
Materiality: 0.70
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/882796/000117184325004091/0001171843-25-004091-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/882796/000117184325004091/f8k_062525.htm
  HTML page:      https://secwatch.observer/filing/0001171843-25-004091

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