other material
confidence high
sentiment positive
materiality 0.65
Krystal Biotech Q3 net loss $29.9M; B-VEC BLA with Priority Review accepted, PDUFA Feb 17, 2023
Krystal Biotech, Inc.
- 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.