---
schema_version: "secwatch.filing_event.v1"
accession: "0001711279-23-000003"
form_type: "8-K"
ticker: "KRYS"
cik: "0001711279"
company_name: "Krystal Biotech, Inc."
filed_at: "2023-01-09T23:59:59+00:00"
generated_at: "2026-06-20T18:00:38.636994+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# Krystal Biotech receives 3-month FDA BLA review extension for B-VEC; new PDUFA date May 19, 2023

## Summary
- FDA extended PDUFA date for B-VEC (beremagene geperpavec) to May 19, 2023 due to major amendment from manufacturing info.
- FDA indicated no Advisory Committee meeting and no REMS program needed for B-VEC application.
- All pre-approval inspections of clinical sites and internal facilities completed successfully.
- Labeling discussions proposed for no later than April 20, 2023.
- CEO expresses disappointment but commits to working with FDA and continuing commercial readiness.

## SEC filing metadata
- accession: 0001711279-23-000003
- form_type: 8-K
- ticker: KRYS
- cik: 0001711279
- company_name: Krystal Biotech, Inc.
- filed_at: 2023-01-09T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1711279/000171127923000003/0001711279-23-000003-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1711279/000171127923000003/krys-20230109.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001711279-23-000003
- JSON: https://secwatch.observer/filing/0001711279-23-000003.json
- Plain text: https://secwatch.observer/filing/0001711279-23-000003.txt

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