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Investing.com - H.C. Wainwright has reiterated its Buy rating and $25.00 price target on Engene Holdings Inc. (NASDAQ:ENGN), currently trading at $6.06, following meetings with the company’s management at its Global Investment Conference. According to InvestingPro data, analyst targets range from $4 to $30, with the consensus maintaining a strong buy recommendation.
The research firm highlighted detalimogene’s differentiation as a non-viral genetic medicine designed for broad community urology adoption, combining clinical activity, tolerability, and ease of use. H.C. Wainwright views detalimogene as remaining competitive against Johnson & Johnson’s recently approved Inlexzo, noting that Engene’s value proposition centers on operational simplicity and cost dynamics.
The firm pointed out that Inlexzo’s safety label presents opportunities for competitors, citing its 24% serious adverse event rate, approximately 7% discontinuation rate, and warnings regarding metastatic risk with delayed cystectomy, bladder perforation contraindication, MRI restrictions, and embryo-fetal toxicity.
Engene expects a pivotal LEGEND interim update in the fourth quarter of 2025, with a BLA filing on track for the second half of 2026 ahead of a potential 2027 launch. The company has received the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation, the first in NMIBC, which allows for increased regulatory interaction and has historically compressed approval timelines.
H.C. Wainwright believes the RMAT designation, combined with operational simplicity, significantly increases detalimogene’s chances of capturing market share in a field where community practices prioritize ease of use over marginal efficacy differences.
In other recent news, enGene Holdings Inc. has completed target enrollment for its pivotal Phase 2 LEGEND trial, which is evaluating detalimogene voraplasmid in patients with high-risk, non-muscle invasive bladder cancer (NMIBC). This milestone involves 100 patients in the pivotal cohort, focusing on those with carcinoma in situ (CIS), with or without concomitant papillary disease. Additionally, the U.S. Food and Drug Administration has granted Regenerative Medicine Advanced Therapy (RMAT) designation to enGene’s lead therapy for treating high-risk bladder cancer, a significant regulatory milestone for the investigational treatment. Analyst firm H.C. Wainwright has reiterated its Buy rating and $25.00 price target on enGene, highlighting the potential of the company’s NMIBC treatment. JMP Securities also maintained its Market Outperform rating with an $18.00 price target, citing expected clinical data updates in the second half of 2025. The LEGEND trial’s Cohort 1 is specifically enrolling BCG-unresponsive CIS patients, with protocol updates aimed at improving complete response durability rates. Both H.C. Wainwright and JMP Securities emphasize the clinical progress and potential operational advantages of enGene’s therapies. These developments are pivotal as the company advances its bladder cancer treatment pipeline.
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