This page is part of our public exclusion list — a transparency tool that shows which companies we screen out and why. It is not investment advice, and it is not an accusation. But it is subject to change as our understanding of the facts evolves.
enGene Holdings develops non-viral gene therapy treatments for bladder cancer using its proprietary DDX delivery platform. Its lead candidate detalimogene voraplasmid achieved a 62% complete response rate at six months in the Phase 2 LEGEND trial for high-risk BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ. The FDA granted both Regenerative Medicine Advanced Therapy and Fast Track designations, and the company plans to submit a Biologics License Application in the second half of 2026. Detalimogene was also selected for the FDA Manufacturing Pilot Program. As a gene therapy product, detalimogene's development required preclinical animal testing including biodistribution, toxicology, and efficacy studies in rodent and potentially larger animal models to satisfy FDA gene therapy regulatory requirements before human dosing.
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A digest of changes to our exclusion list — new additions, removals, and the evidence behind them. We review the list continuously as new evidence surfaces.
Companies appear on our exclusion list based on our investment judgment — not because they've done anything illegal. This is a difference of values and opinion, not an accusation of wrongdoing. Exclusion does not constitute a recommendation against investing in any company, and absence from the list does not constitute a recommendation to invest.
This information is provided for educational and transparency purposes only and should not be relied upon as investment advice. Data is drawn from independent watchdogs, NGOs, government registries, and Ethical Capital's ongoing research — see Research Sources for the full list.
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