enGene soars on positive detalimogene data

11 November 2025

Canadian genetic medicines company enGene Holdings (Nasdaq: ENGN) saw its shares rocket as much as 65% to $9.93 in pre-market trading, after it reported additional preliminary data from the pivotal cohort of its ongoing, Phase II LEGEND trial of detalimogene voraplasmid (also known as detalimogene and previously EG-70).

The drug is being investigated in high-risk, Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) patients with carcinoma in situ (CIS) with or without concomitant papillary disease.

Detalimogene’s preliminary data so far and differentiated profile continue to support the company’s planned Biologics License Application (BLA) submission with the US Food and Drug Administration (FDA) in the second half of 2026, said enGene.

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