Wells Fargo upgrades enGene Therapeutics to Overweight from Equal-Weight, raises price target to $6 from $2

Raymond James reiterated an Outperform rating and $4.00 price target on Engene Holdings (ENGN) after positive bladder cancer trial data. The stock is down 79% from its 52-week high but has a strong balance sheet. The FDA meeting feedback and trial results suggest potential approval by 2026. Other analysts also commented on the company's prospects.

enGene Therapeutics Inc. (ENGN) filed an SEC Form 8-K — Results of Operations and Financial Condition. Corporate Presentation Non-Viral Genetic Medicine Disclaimers Cautionary Statement Regarding Forward-Looking Statements This Presentation contains certain forward-looking statements within the meaning of the federal securities laws and "forward-looking information" within the mea

enGene Therapeutics reported positive Phase 2 LEGEND trial data for detalimogene in bladder cancer patients. The company plans to submit a BLA based on data from 125 patients.

enGene Therapeutics reported updated results from its LEGEND trial for detalimogene, showing improved efficacy in treating BCG-unresponsive NMIBC. Key metrics include a 56% complete response rate and a 43% 12-month duration of response. The company plans to submit a BLA by year-end 2026, with potential FDA approval in 2027. Detalimogene demonstrated a favorable safety profile, with only 2% of patients experiencing serious adverse events.

enGene Therapeutics (NASDAQ:ENGN) reported updated Phase 2 LEGEND trial data for its bladder cancer therapy, detalimogene. The complete response rate was 56%, with a 43% duration of response of at least 12 months. The company aims to submit a Biologics License Application by year-end 2026. Safety data showed 59% of patients experienced treatment-related adverse events, mostly mild. The FDA has granted the therapy Regenerative Medicine Advanced Therapy and Fast Track designations.

enGene Therapeutics (ENGN) aims to submit a BLA for detalimogene by year-end 2026 and complete the process in H1 2027, with potential FDA approval in 2027. In Cohort 1, 4% of 125 patients experienced Grade 3 treatment-related adverse events, with no Grade 4 or 5 events reported.