Krystal Biotech receives positive CHMP opinion for VYJUVEK in EU; EC decision expected Q2 2025

Krystal Biotech, Inc.

CHMP recommends EC approval of VYJUVEK for DEB wounds, including from birth, with option for at-home administration.
Final EC decision anticipated in Q2 2025, applicable to EU member states plus Iceland, Norway, Liechtenstein.
Positive opinion based on Phase 1/2 GEM-1 and Phase 3 GEM-3 data showing durable wound closure.
Company expects first European launch in Germany around mid-2025, followed by France later in 2025.
VYJUVEK previously approved by FDA in May 2023 for DEB patients aged 6 months and older in the U.S.

This headline and bullets were generated automatically by deepseek-v4-flash:cloud@v2 from the public filing. Read the source on SEC.gov before relying on any specific claim. Not investment advice. See methodology for how this pipeline works.