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enGene
enGene (ENGN) investor relations material
enGene Guggenheim Securities Emerging Outlook: Biotech Summit 2026 summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Guggenheim Securities Emerging Outlook: Biotech Summit 2026 summary11 Feb, 2026
Product profile and market positioning
Detalimogene offers competitive efficacy and best-in-class tolerability, with low treatment discontinuation and interruptions, fitting well into community urology practices due to its non-viral, easy-to-handle formulation and flexible storage requirements.
Over 80% of NMIBC patients are managed in community settings, where throughput, ease of use, and practice economics are highly valued.
Recent market innovations, such as J&J's INLEXZO and TAR-200, set new benchmarks for efficacy and pricing, influencing detalimogene's commercial strategy.
Detalimogene's low cost of goods provides pricing flexibility, allowing adaptation to evolving market benchmarks.
Clinical development and regulatory progress
The pivotal LEGEND study fully enrolled 125 patients, exceeding the initial target due to high interest.
Interim data showed a six-month complete response rate of 62%, with low adverse events and minimal treatment interruptions, supporting a best-in-class tolerability profile.
Durability data are promising, with all evaluable patients at nine months maintaining complete response, and expectations for strong 12-month durability.
The primary endpoint was updated to align with FDA standards, focusing on complete response rate at any time.
Top-line data are expected in the second half of the year, with regulatory filing planned shortly after, supported by strong FDA engagement and special designations (RMAT, CDRP).
Manufacturing, study design, and future expansion
Manufacturing is nearly complete, with a unique non-viral process and ongoing FDA validation, de-risked by early and open regulatory dialogue.
The study includes 94 post-amendment patients (driving results) and 31 pre-amendment patients (minimal impact), with regulatory discussions ongoing regarding analysis.
Additional LEGEND study cohorts (BCG-naive, BCG-exposed, papillary) are deprioritized for now but may support future label expansions and guideline inclusion.
Intermediate-risk NMIBC is a future target, leveraging detalimogene's ease of use and tolerability.
How does TAR-200 pricing inform your strategy?
What regulatory factors de-risk your filing?
Rationale for intermediate risk NMIBC expansion
Partial view of Summaries dataset, powered by Quartr API
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Next enGene earnings date
Q1 202612 Mar, 2026
enGene
Next enGene earnings date
Q1 202612 Mar, 2026
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Frequently asked questions
enGene Holdings Inc. operates through its subsidiary, enGene, Inc., as a clinical-stage biotechnology company focused on developing genetic medicines. The company specializes in the delivery of therapeutics to mucosal tissues and other organs using non-viral methods. Its primary product candidate is EG-70 (detalimogene voraplasmid), a non-viral immunotherapy aimed at treating non-muscle invasive bladder cancer in patients unresponsive to traditional treatments. The company is headquartered in Montreal, Quebec, Canada, and its shares are listed on the NASDAQ.
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