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

Krystal Biotech, Inc.

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.

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