enGene Holdings Inc. (NASDAQ:ENGN) stock is edging higher on Tuesday, with a session volume of 18.62 million compared to an average volume of 266.85 thousand, as per data from Benzinga Pro.
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enGene on Tuesday reported additional preliminary data from the pivotal cohort of its ongoing, Phase 2 LEGEND trial of detalimogene voraplasmid (also known as detalimogene and previously EG-70) in high-risk bladder cancer patients.
The trial included 99 patients with bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without concomitant papillary disease.
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Data
The preliminary analysis included 62 patients at 3 months and 37 patients at 6 months.
Data from 62 patients enrolled under the amended protocol with at least one post-baseline disease assessment demonstrated:
- 63% complete response (CR) rate at any time (n=62).
- 56% CR rate at 3 months (n=62).
- 62% CR rate at 6 months (n=37), with four patients having successfully converted to CR post reinduction.
- All five patients who completed the 9-month assessment had a CR.
The company completed enrollment of 125 patients in the pivotal cohort, exceeding its target by 25%
In September 2024, enGene reported preliminary data from 21 patients in the pivotal cohort of LEGEND who were enrolled before implementing a protocol amendment in the fourth quarter of 2024.
An additional 10 patients were enrolled under the prior protocol for a total of 31 patients.
Preliminary efficacy data for patients enrolled before implementing the protocol amendment demonstrated a markedly lower 12-month CR rate than that of U.S. Food and Drug Administration (FDA)-approved products for BCG-unresponsive NMIBC.
What Next?
“We are highly encouraged with the preliminary data from our LEGEND study, which support our planned BLA filing,” said Ron Cooper, President and CEO. “Based on the emerging clinical profile and detalimogene’s differentiated ease of use, we continue to believe there is a substantial commercial opportunity for detalimogene if approved.”
enGene expects to provide a data update on the LEGEND trial’s pivotal cohort in the second half of 2026.
The company continues to expect to file the FDA marketing application in the second half of 2026, with a potential FDA approval in 2027.
ENGN Price Action: enGene Holdings shares were up 64.73% at $9.90 at the time of publication on Tuesday. The stock is trading at a new 52-week high, according to Benzinga Pro data.
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