Krystal Biotech Wins RMAT for Inhaled KB707 After 36% ORR, Schedules Q4 2025 Results
Krystal Biotech received FDA RMAT designation for inhaled KB707 in advanced NSCLC after a 36% ORR and expects interim analysis of a KB707-plus-chemo trial in H2 2026. The company will report Q4 and full-year 2025 results on February 17, 2026, before U.S. markets and host an 8:30 am ET webcast.
1. RMAT Designation for KB707
The FDA granted RMAT designation to Krystal’s inhaled KB707 for advanced or metastatic non-small cell lung cancer based on a 36% objective response rate observed in heavily pretreated patients during early studies.
2. Planned Trial Update and Interim Analysis
Krystal plans a single registrational trial comparing KB707 plus chemotherapy against chemotherapy alone, with an interim efficacy analysis slated for the second half of 2026 to support a potential regulatory submission.
3. Q4 and Full-Year 2025 Earnings Announcement
Krystal Biotech will report fourth-quarter and full-year 2025 financial results on February 17, 2026 before U.S. markets and host an 8:30 am ET webcast to review its financial performance and pipeline progress.