ENGN Stock Soars On Hopeful Data From Bladder Cancer Study

• The study was evaluating the experimental drug in certain high-risk, Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) patients. 
• Engene said on Tuesday that preliminary data from the pivotal cohort of its mid-stage trial shows that out of 37 patients evaluated at six months, 62% had a complete response rate.

Shares of enGene Holdings Inc. (ENGN) jumped 39% on Tuesday morning after the company said that its Detalimogene voraplasmid demonstrated an improved complete response rate of 62% at six months in a study.  

The study was evaluating the experimental drug in certain high-risk, Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) patients.

NMIBC occurs when cancer cells grow in the tissues that line the interior of the bladder, but the cancer has not yet penetrated the muscle of the bladder wall. Patients suffering from high-risk NMIBC who are unresponsive to the standard of care, Bacillus Calmette-Guérin (BCG), face high rates of disease recurrence, and the standard treatment is often radical cystectomy, which involves removing the bladder.

What Does The Study Show?

Engene said on Tuesday that preliminary data from the pivotal cohort of its mid-stage trial shows that out of 37 patients evaluated at six months, 62% had a complete response rate, and all five patients who completed the 9-month assessment had a complete response.

Complete response rate is the percentage of patients whose cancer disappears completely after treatment, a measure often used in cancer research to evaluate a therapy's effectiveness.

The patients in the cohort were evaluated under an amended protocol adopted in the fourth quarter of 2024 and designed to align the trial with the American Urological Association’s Guidelines. Before the protocol amendment, the complete response rate at 6 months was only 41%.

The company is now looking forward to submitting an application for approval of the cancer therapy to the U.S. Food and Drug Administration in the second half of 2026 and is hopeful for approval in 2027.

Safety Concerns

According to Engene, the company has enrolled 125 patients in the pivotal cohort of its trial, and 42% of them experienced a treatment-related adverse event. However, only 1.6% experienced dose interruptions due to treatment-related adverse events, and only 0.8% experienced dose discontinuations.

Overall, the data demonstrates a favorable tolerability profile, the company said.

How Did Stocktwits Users React?

On Stocktwits, retail sentiment around ENGN stock jumped from ‘neutral’ to ‘extremely bullish’ territory over the past 24 hours while message volume rose from ‘low’ to ‘extremely high’ levels.

ENGN stock is up by 25% this year. 

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