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On Tuesday, H.C. Wainwright maintained a positive outlook on Engene Holdings Inc. (NASDAQ: ENGN), reiterating a Buy rating and a $25.00 price target. The stock, currently trading at $5.24, shows significant upside potential according to analyst consensus, with targets ranging from $7 to $34. InvestingPro analysis indicates the stock is currently undervalued. The firm’s analyst Andres Maldonado highlighted the potential of enGene’s leading drug candidate, detalimogene voraplasmid, which is undergoing a critical LEGEND study for high-risk non-muscle invasive bladder cancer (HR-NMIBC) with carcinoma in situ (CIS) in patients who have not responded to Bacillus Calmette-Guérin (BCG) treatment. With a market capitalization of $267 million and an overall Financial Health score rated as ’FAIR’ by InvestingPro, the company shows promise despite recent market volatility.
Maldonado noted that early results from the study are encouraging, with detalimogene voraplasmid showing a 71% complete response (CR) rate at any time and a 47% CR rate at six months. These figures are considered favorable when compared to recent drug approvals in the same category, which have seen CR rates ranging from 41% to 62% at any time.
The analyst pointed out that enGene is on track to provide an additional interim update from the pivotal cohort in the second half of 2025, with a final data readout and a Biologics License Application (BLA) submission expected in 2026.
The LEGEND study’s positive early data is a significant milestone for enGene, as it could position detalimogene voraplasmid as a strong candidate for addressing the unmet medical needs of HR-NMIBC patients. The anticipated updates in the latter half of 2025 and the subsequent BLA submission in 2026 are key events that investors and stakeholders are likely to watch closely. The stock has seen a challenging period, with a -68.3% return over the past year, though InvestingPro subscribers can access detailed analysis of the company’s growth potential and over 30 additional financial metrics.
Engene Holdings Inc. is focused on advancing its pipeline of innovative treatments, with detalimogene voraplasmid at the forefront of its efforts to combat bladder cancer. The company’s commitment to addressing HR-NMIBC is reflected in the ongoing research and development, aiming to improve outcomes for patients with this challenging condition.
In other recent news, Engene Holdings Inc. has announced a sales agreement with Jefferies LLC, allowing the company to sell up to $100 million of its common shares. This move is part of Engene’s strategy to strengthen its capital position, with Jefferies facilitating sales "at the market" while adhering to legal and market regulations. In another development, Piper Sandler initiated coverage on Engene with an Overweight rating and a $26.00 price target, citing the potential of the company’s gene therapy asset, detalimodene, for treating non-muscle invasive bladder cancer. Piper Sandler expects substantial revenue growth from detalimodene, forecasting U.S. revenue to exceed $500 million by 2033. Additionally, H.C. Wainwright began coverage of Engene with a Buy rating and a $25.00 price target, highlighting the promising data from the company’s lead candidate, detalimogene voraplasmid. The clinical results from the LEGEND trial have shown a complete response rate of 71% at any time for high-risk non-muscle invasive bladder cancer patients, which is notable compared to recent approvals. These recent developments underscore Engene’s strategic efforts and the potential impact of its therapeutic candidates in the evolving cancer treatment market.
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