Clinical Trials & EfficacyCretostomogene demonstrated a 75.5% anytime complete response rate with no treatment-related discontinuations, indicating a strong efficacy and safety profile.
Market OpportunityCG Oncology is developing an oncolytic virus that is considered potently effective and safe, with the potential to dominate the intermediate-/high-risk NMIBC markets.
Regulatory PathwayCG Oncology has initiated the rolling BLA submission process for creto, which is supported by Breakthrough and Fast Track designations, potentially allowing for an accelerated approval path.