FDA backs KB707 lung cancer immunotherapy with RMAT designation

Krystal Biotech (NASDAQ: KRYS) announced on February 9, 2026 that the FDA granted RMAT designation to KB707 for treatment of advanced or metastatic non-small cell lung cancer (NSCLC). The designation recognizes preliminary clinical activity from the ongoing KYANITE-1 trial and offers expedited development benefits such as rolling review and intensive FDA interaction. Enrollment in KYANITE-1 continues; additional data will be presented at upcoming scientific conferences and the trial is listed as NCT06228326.

https://www.stocktitan.net/news/KRYS/krystal-biotech-announces-rmat-designation-granted-by-fda-to-kb707-jsort86q2afa.html