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Robust efficacy signals and bladder-sparing potential in a high-need indication can attract attention from investors and raise likelihood of FDA dialogue, potentially triggering a re-rating for CGON given the single-arm but strong phase 3 data.
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CG Oncology disclosed pivotal Phase 3 BOND-003 Cohort C results for cretostimogene grenadenorepvec in high-risk BCG-unresponsive NMIBC with CIS, showing a 75.5% complete response rate and durable responses (median duration at least 27.9 months). Bladder preservation remained high (89% at 12 months, 81% at 24 months) with a favorable safety profile and high progression-free survival (96.6% at 48 weeks and 96 weeks), suggesting potential for FDA consideration as a bladder-sparing monotherapy if confirmed in ongoing studies.
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