enGene reports 54% complete response in Phase 2 bladder cancer trial, targets 2H 2026 BLA

Filed July 17, 2026 · Period ending July 17, 2026 · ~1 min read

Key Changes

• high

  Interim Phase 2 data showed 54% complete response rate for detalimogene in BCG-unresponsive bladder cancer, with 96.8% of patients free from progression to advanced disease (125 patients, 5.5-month median follow-up).

  Exhibit 99.1 view on EDGAR →
• high

  Company expects to file BLA in second half 2026 following 12-month pivotal cohort data, with potential FDA approval and platform designation in 2027. FDA previously indicated Phase 2 data may potentially support BLA approval.

  Exhibit 99.1 view on EDGAR →
• high

  Safety profile showed 91.3% of treatment-related adverse events were Grade 1-2, with only 4.8% of patients experiencing Grade 3+ events. Dose interruptions and discontinuations each occurred in 2.4% of patients.

  Exhibit 99.1 view on EDGAR →