Clinical Trial ResultsThe trial demonstrated a median PFS of 19.4 months in combination therapy versus 11.0 months with pembrolizumab alone, showing an impressive 8+ month benefit in median PFS.
Regulatory PathwayDecember meeting with FDA could help pave path forward for Cylembio.
Strategic PlanningThe management intends to file for approval by the end of the year and is seeking Priority Review, indicating a proactive strategy despite challenges.