- On Nov 29, KRYS reported positive topline results from their pivotal phase 3 trial of "VYJUVEK™ in Patients with Dystrophic Epidermolysis Bullosa (DEB).
- Pivotal GEM-3 trial met its primary and secondary endpoints, i.e. the differences in complete wound healings between treatment & placebo at 6 months and 3 months, p<0.005 in both.
- KRYS plans to file the BLA (Biologic License Application) of VYJUVEK in DEB in H1 2022 and submit an application in Europe soon after.
- I look at KRYS' DEB p3 data, DEB treatment space and share my thoughts here.
For further details see:
Krystal Biotech: Healing 'Butterfly Children' One Topical, Re-Dosable Gene Therapy At A Time