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enGene Holdings ( (ENGN) ) has provided an announcement.
enGene Holdings announced that its investigational gene therapy, detalimogene voraplasmid, has been selected for the FDA’s Chemistry, Manufacturing, and Controls Development and Readiness Pilot Program. This inclusion is expected to enhance the company’s manufacturing readiness and aligns with its clinical development progress, as evidenced by promising results from the LEGEND trial. The selection underscores the potential of detalimogene in addressing unmet medical needs in NMIBC and supports enGene’s commitment to robust manufacturing practices. The company plans to submit a Biologics License Application by the second half of 2026.
The most recent analyst rating on (ENGN) stock is a Buy with a $18.00 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 company specializing in non-viral genetic medicines. The company focuses on developing innovative gene therapies, particularly for high-risk, non-muscle invasive bladder cancer (NMIBC). Their products are designed to offer alternative solutions to traditional viral-based gene therapies, utilizing their proprietary Dually Derivatized Oligochitosan (DDX) platform.
Average Trading Volume: 1,284,940
Technical Sentiment Signal: Buy
Current Market Cap: $510.8M
Find detailed analytics on ENGN stock on TipRanks’ Stock Analysis page.