secwatch.observer — SEC 8-K summary
======================================

Issuer:     Krystal Biotech, Inc. (KRYS)
CIK:        0001711279
Form:       8-K
Filed at:   2022-08-18T23:59:59+00:00
Accession:  0001711279-22-000052
Event type: regulatory
Sentiment:  positive
Materiality: 0.85
Item codes: 7.01, 8.01, 99.1, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

- 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.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1711279/000171127922000052/0001711279-22-000052-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1711279/000171127922000052/krys-20220818.htm
  HTML page:      https://secwatch.observer/filing/0001711279-22-000052

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