Krystal Biotech Shares Surge on Expanded FDA Approval
19.09.2025 - 08:00:05Expanded Label Unlocks Major Market Opportunity
Gene therapy specialist Krystal Biotech has achieved a significant regulatory milestone that is driving substantial investor interest. The company’s flagship treatment, VYJUVEK, has received a broadened approval from the U.S. Food and Drug Administration that dramatically increases its commercial potential and simplifies its administration.
The FDA’s updated approval represents a fundamental shift for VYJUVEK’s market positioning. Treatment can now begin immediately after birth, removing all previous age restrictions and substantially widening the eligible patient population. More significantly, the therapy can now be administered in home settings by patients and their caregivers rather than requiring clinical visits.
Another critical change eliminates the previous 24-hour waiting period for dressing changes, making the entire treatment process considerably... Read more...