On Monday, H.C. Wainwright began coverage on Engene Holdings Inc. (NASDAQ:ENGN) with a Buy rating and a price target of $25.00. The firm's analyst highlighted the potential of enGene's gene therapy platform and its lead candidate, detalimogene voraplasmid, which is being tested for high-risk non-muscle invasive bladder cancer (HR-NMIBC).
The DDX platform developed by enGene is central to its strategy, as it allows the delivery of genetic material directly to mucosal tissues without the complications commonly associated with viral vector-based systems. This innovative approach has positioned enGene as a notable player in the evolving NMIBC treatment market.
Engene's detalimogene is currently under evaluation in the LEGEND clinical study, specifically targeting patients with HR-NMIBC that have not responded to Bacillus Calmette-Guérin (BCG) treatment. The clinical data revealed so far has been promising, with a complete response (CR) rate of 71% (15 out of 21 patients) at any time and a 47% CR at six months, which includes a 51% six-month Kaplan-Meier estimate.
These early clinical results are significant when compared to recent approvals in the same therapeutic area, which have reported CRs at any time ranging between 41% and 62%. The analyst's positive outlook on Engene Holdings reflects the company's strong clinical performance and the potential market impact of its lead therapeutic candidate.
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