KRYS - FDA accepts Krystal Biotech's biologics license application for genetic skin disorder DEB
- Krystal Biotech ( NASDAQ: KRYS ) on Thursday said the U.S. FDA had accepted its biologics license application for its gene therapy B-VEC for the treatment of dystrophic epidermolysis bullosa (DEB).
- DEB is a genetic skin disorder affecting skin and nails that usually presents at birth.
- The FDA said it would decide upon the application by Feb. 17, 2023, or the so-called Prescription Drug User Fee Act date.
- The FDA granted the application a priority review designation.
- The agency said it is not currently planning to hold an advisory committee meeting to discuss the application.
- KRYS stock -1.7% to $73.14 in postmarket trading.
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FDA accepts Krystal Biotech's biologics license application for genetic skin disorder DEB