---
schema_version: "secwatch.filing_event.v1"
accession: "0001711279-22-000052"
form_type: "8-K"
ticker: "KRYS"
cik: "0001711279"
company_name: "Krystal Biotech, Inc."
filed_at: "2022-08-18T23:59:59+00:00"
generated_at: "2026-06-23T22:51:17.374402+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# FDA accepts Krystal Biotech's BLA for B-VEC with Priority Review; PDUFA Feb 2023

## Summary
- FDA accepted BLA for B-VEC (gene therapy) to treat dystrophic epidermolysis bullosa (DEB).
- Granted Priority Review; PDUFA target action date set for February 17, 2023.
- FDA stated it does not currently plan to hold an advisory committee meeting on this BLA.
- B-VEC previously received Fast Track and Regenerative Medicine Advanced Therapy (RMAT) designations.
- Company plans to submit marketing authorization application to EMA in H2 2022.

## SEC filing metadata
- accession: 0001711279-22-000052
- form_type: 8-K
- ticker: KRYS
- cik: 0001711279
- company_name: Krystal Biotech, Inc.
- filed_at: 2022-08-18T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 7.01, 8.01, 99.1, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1711279/000171127922000052/0001711279-22-000052-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1711279/000171127922000052/krys-20220818.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001711279-22-000052
- JSON: https://secwatch.observer/filing/0001711279-22-000052.json
- Plain text: https://secwatch.observer/filing/0001711279-22-000052.txt

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