Krystal Biotech PDUFA delay ‘a minor setback,’ says Chardan

After Krystal Biotech announced the PDUFA date for B-VEC in dystrophic epidermolysis bullosa has been postponed by three months to May following additional manufacturing information having been submitted to the agency in December that the FDA is considering as a major amendment to the BLA, requiring additional review, Chardan analyst Geulah Livshits called the delay "a minor setback for Krystal." Livshits, who remains bullish on a potential approval decision for B-VEC and 2023 launch, citing the strength of the phase 3 data and decision from the FDA not to convene an advisory committee meeting, has a Buy rating and $133 price target on Krystal shares.