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enGene Holdings Achieves Key Milestone in LEGEND Trial and Secures RMAT Designation

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enGene Holdings Achieves Key Milestone in LEGEND Trial and Secures RMAT Designation

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enGene Holdings ( (ENGN) ) has provided an announcement.

enGene Holdings has reached a significant milestone by achieving target enrollment for its pivotal LEGEND trial cohort in high-risk BCG-unresponsive NMIBC with carcinoma in situ. The company plans to update pivotal cohort data in the fourth quarter of 2025 and aims to submit a Biologic License Application in the second half of 2026. With $224.9 million in cash and marketable securities, enGene is financially positioned to support operations into 2027. The recent RMAT designation for detalimogene enhances enGene’s regulatory pathway, potentially accelerating its journey toward commercialization, while key management appointments strengthen its strategic capabilities.

The most recent analyst rating on (ENGN) stock is a Buy with a $23.00 price target. To see the full list of analyst forecasts on enGene Holdings stock, see the ENGN Stock Forecast page.

Spark’s Take on ENGN Stock

According to Spark, TipRanks’ AI Analyst, ENGN is a Neutral.

enGene Holdings shows significant financial challenges, with no revenue generation and persistent losses impacting both income and cash flow statements. Technical indicators suggest bearish momentum, with the stock underperforming key moving averages. The valuation is further hampered by a negative P/E ratio and absence of dividends. These factors collectively result in a low overall stock score, highlighting the company’s urgent need to establish a revenue model and improve operational efficiency.

To see Spark’s full report on ENGN stock, click here.

More about enGene Holdings

enGene Holdings Inc. is a clinical-stage, non-viral gene therapy company focused on developing innovative treatments for high-risk, non-muscle invasive bladder cancer (NMIBC). The company is advancing its lead product, detalimogene, which has received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA, offering several regulatory advantages.

Average Trading Volume: 124,124

Technical Sentiment Signal: Buy

Current Market Cap: $321.5M

Learn more about ENGN stock on TipRanks’ Stock Analysis page.

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