VYJUVEK Revenue Growth
Net VYJUVEK revenue for Q3 was $97.8 million, contributing to a total of over $623 million since launch. Gross margins were 96% for the quarter.
International Expansion Success
VYJUVEK launched in Germany, France, and Japan, with successful pricing negotiations in Japan. The launch in Germany saw prescriptions from over 10 centers.
FDA Label Update for VYJUVEK
The FDA approved an updated VYJUVEK label, expanding the eligible patient population to DEB patients from birth and providing dosing flexibility.
Strong Financial Position
The company ended the quarter with over $864 million in cash and investments, maintaining a strong balance sheet to support commercial and pipeline activities.
Platform Therapy Designation
The FDA granted a platform therapy designation for the HSV-1 gene delivery platform, potentially accelerating approval pathways for programs like KB801.