Krystal Biotech Provides Update on EMA's Ongoing Regulatory Review of B-VEC for Dystrophic Epidermolysis Bullosa
Portfolio Pulse from
Krystal Biotech announced that the EMA's CHMP has postponed the oral explanation for B-VEC, a treatment for dystrophic epidermolysis bullosa, and requested written responses instead. The CHMP opinion is now expected in Q1 2025, with a potential launch in Germany in Q2 2025.
December 09, 2024 | 9:30 pm
News sentiment analysis
Sort by:
Ascending
NEUTRAL IMPACT
Krystal Biotech's B-VEC treatment for DEB is facing a delay in the EMA's CHMP review process, with a decision now expected in Q1 2025. The company anticipates launching in Germany by Q2 2025.
The delay in the CHMP's opinion on B-VEC could impact investor sentiment, but the absence of major objections and the expected launch timeline in Germany may mitigate negative effects. The news is highly relevant to Krystal Biotech as it directly affects their product's regulatory approval and market entry.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100