Krystal Biotech (KRYS) announced that the European Medicines Agency’s, or EMA’s, Committee for Medicinal Products for Human Use, or CHMP, cancelled the Oral Explanation regarding the company’s marketing authorization application for beremagene geperpavec-svdt, or B-VEC, for the treatment of dystrophic epidermolysis bullosa, or DEB, that was scheduled for December 6 and asked the company to submit written responses to the remaining outstanding issues. There are no major objections outstanding from the EMA with respect to the full approval of B-VEC. The company now anticipates a CHMP opinion in Q1 2025 while the launch timelines remain unchanged with a commercial launch in Germany still planned for Q2 2025.
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