KB707 is Krystal Biotech's investigational redosable immunotherapy gene medicine for advanced or metastatic non-small cell lung cancer. It is designed for localized tumor microenvironment expression of IL-2 and IL-12 and is being evaluated as inhaled treatment in the ongoing KYANITE-1 study. FDA granted RMAT designation in February 2026.
The FDA fast-tracked an inhalable gene therapy for advanced lung cancer after an early 11-patient trial showed tumour shrinkage in three patients and disease stabilization in five. Larger studies involving about 250 patients are underway.
Krystal Biotech said IOLITE enrollment for KB803 is complete and it remains on track for KB803 and KB801 registrational data readouts in 2026. The company also reported FDA platform technology designations for KB407 and KB111 and continued VYJUVEK expansion.
Krystal Biotech is set to report fourth-quarter results with analysts expecting $1.58 a share on $106.16 million in revenue. Investors are watching Vyjuvek growth and pipeline programs including KB801, KB407 and KB707.
Krystal Biotech posted Q4 2025 net revenue of $107.1 million from Vyjuvek sales, with full-year revenue reaching $389.1 million. The company expanded to over 90 patients across Germany, France, and Japan while advancing its pipeline with new FDA designations.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT06228326 |
A Study Assessing KB707 for the Treatment of Advanced Solid Tumor Malignancies Affecting the Lungs |
RECRUITING | PHASE1/PHASE2 |
| NCT05970497 |
A Study Assessing KB707 for the Treatment of Locally Advanced or Metastatic Solid Tumors |
RECRUITING | PHASE1/PHASE2 |
