KRYSTAL BIOTECH INC · Data as of 2026-09-08
2026
We have enrolled three patients with Gorlin syndrome in OPAL-1 and expect to provide an interim clinical update on these patients as well as outline potential development plans for intratumoral KB707 for the treatment of Gorlin syndrome later this year.Source filing
2H 2026
The Company expects to file multiple additional marketing authorization applications for VYJUVEK in 2H 2026, including in Switzerland and Australia.Source filing
Late 2026
We expect to complete enrollment and report HALITE-1 interim study results before the end of the year.Source filing
Late 2026
We plan to submit the results from HALITE-1 along with the registrational study design and scale for discussions with the FDA before year end to enable a potential registrational study start in 2027.Source filing
Late 2026
The Company expects to complete enrollment in 2Q 2026 and report results before year end.Source filing
Late 2026
We expect to complete enrollment and report top-line results from EMERALD-1 before the end of the year.Source filing
4Q 2026
The Company's registrational, intra-patient, double-blind, de-centralized, placebo-controlled study (IOLITE) with crossover design evaluating KB803 for the treatment and prevention of corneal abrasions in DEB patients was fully enrolled in April and is on track for a top-line data readout in 4Q 2026.Source filing
4Q 2026
The Company will share the design and associated statistical analysis of the registrational study following alignment with the FDA, which is expected in 4Q 2026, and is on track to initiate the registrational study in 2027.Source filing
2027
We expect to report interim safety and SERPINA1 delivery data from the repeat dose Cohort 2B in 2027.Source filing
H1 2027
We expect to complete enrollment later this year and report updated interim clinical results, as well as potential registrational study plans, in the first half of 2027.Source filing