secwatch.observer — SEC 8-K summary
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Issuer:     Krystal Biotech, Inc. (KRYS)
CIK:        0001711279
Form:       8-K
Filed at:   2022-11-07T23:59:59+00:00
Accession:  0001711279-22-000061
Event type: other_material
Sentiment:  positive
Materiality: 0.65
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Krystal Biotech Q3 net loss $29.9M; B-VEC BLA with Priority Review accepted, PDUFA Feb 17, 2023
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- Cash and investments $407M at quarter end; net loss $29.9M ($1.17 per share) vs $15.6M loss in Q3 2021.
- FDA accepted B-VEC BLA for dystrophic epidermolysis bullosa with Priority Review; PDUFA target Feb 17, 2023.
- No Advisory Committee meeting or REMS needed after mid-cycle review; EMA Pediatric Committee gave positive opinion.
- R&D spent $11.5M (Q3 2022); pipeline: KB407 (CF) IND accepted, dosing starts Q4 2022; KB105, KB104, KB301 advancing.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1711279/000171127922000061/0001711279-22-000061-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1711279/000171127922000061/krys-20221107.htm
  HTML page:      https://secwatch.observer/filing/0001711279-22-000061

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