enGene appoints bladder cancer expert as chief medical officer

BOSTON/MONTREAL - Clinical-stage genetic medicine company enGene Holdings Inc. (NASDAQ:ENGN), currently valued at $330 million with shares trading at $6.45, has appointed Hussein Sweiti, M.D., MSc, as Chief Medical Officer, effective September 29, the company announced Tuesday. According to InvestingPro analysis, the stock appears undervalued based on its Fair Value metrics.

Dr. Sweiti, a surgical oncologist with over 15 years of experience, previously served as Global Medical Head of Oncology Clinical Development at Johnson & Johnson, where he led the bladder cancer portfolio. He was involved in FDA interactions that resulted in J&J’s recent approval for a treatment in high-risk, BCG-unresponsive non-muscle invasive bladder cancer (NMIBC).

The appointment comes as enGene prepares for a planned Biologics License Application (BLA) submission in the second half of 2026 for its lead candidate detalimogene voraplasmid, which is being evaluated in patients with high-risk NMIBC.

"After reaching target enrollment in detalimogene’s pivotal NMIBC clinical trial, Hussein is exactly the right fit for enGene as we transition our focus to regulatory filing and commercialization," said Ron Cooper, Chief Executive Officer of enGene, according to the press release. Analysts share this optimism, with price targets ranging from $4 to $30, according to InvestingPro data, which offers 12+ additional insights about the company’s growth potential.

Detalimogene was developed using the company’s Dually Derivatized Oligochitosan (DDX) platform, a non-viral genetic medicine delivery technology. The investigational treatment has received both Regenerative Medicine Advanced Therapy and Fast Track designations from the FDA.

The company’s LEGEND Phase 2 trial includes a pivotal cohort of approximately 100 patients with high-risk, BCG-unresponsive NMIBC with carcinoma in situ. This cohort is designed to serve as the basis for the planned BLA filing.

Dr. Sweiti received his medical degree from the University of Heidelberg and is board certified in surgical oncology with a Certification in Medical Oncology from the European Society for Medical Oncology. The company maintains a strong financial position with a current ratio of 10.34 and relatively low debt-to-equity of 0.16, suggesting solid financial stability as it advances its clinical programs.

In other recent news, Engene Holdings Inc. has completed the 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). The trial has successfully enrolled 100 patients in its pivotal cohort, focusing on those with carcinoma in-situ (CIS), with or without concomitant papillary disease. Additionally, H.C. Wainwright has reiterated its Buy rating on Engene Holdings, maintaining a $25 price target. The firm emphasizes the operational advantages of detalimogene, particularly its differentiation as a non-viral genetic medicine designed for broad community urology adoption. H.C. Wainwright believes that Engene’s approach remains competitive against Johnson & Johnson’s recently approved Inlexzo. The research firm also highlighted that investor focus should not solely be on complete response rates but also on the operational simplicity and cost dynamics of Engene’s treatment. These developments are crucial as the company prepares for the release of fourth-quarter 2025 interim data for detalimogene.

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