ENGN Stock Forecast & Price Target

enGene Holdings Inc. has gained significant momentum with the designation of detalimogene as a Regenerative Medicine Advanced Therapy (RMAT), positioning it to secure a substantial share of the market, especially within community practice settings. Furthermore, the company has additional growth potential through its LEGEND study cohorts, which may broaden the addressable market by targeting earlier disease stages and patients under active surveillance. Although research and development expenses have increased to $22.6 million in Q3 2025 from $11.5 million a year prior, this rise reflects investment in key initiatives such as manufacturing and clinical trials, indicating a commitment to advancing its innovative gene therapy pipeline.

The negative outlook for enGene Holdings Inc. is primarily driven by concerns regarding potential failures to achieve regulatory approval, which could adversely affect the company's stock price. Additionally, the operational burden associated with TAR-200, characterized by a 24% serious adverse event rate and approximately 7% discontinuation rate, raises questions about its market acceptance and overall commercial viability. Furthermore, competition from alternative therapies that may offer less procedural burden could further hinder enGene's ability to gain traction in the biotechnology space.