Promising Advancements in enGene Holdings’ Clinical Trials Justify Buy Rating

H.C. Wainwright analyst Andres Y. Maldonado has maintained a Buy rating on enGene Holdings, setting a price target of $25.00, citing promising advancements in clinical trials. The Phase 2 LEGEND trial data shows improved response rates for detalimogene voraplasmid in treating high-risk, BCG-unresponsive non-muscle invasive bladder cancer. The treatment's safety, ease of use, and competitive pricing enhance its market potential. Additionally, Raymond James upgraded the stock to a Buy with a $27.00 price target, reflecting confidence in its future success.

Exchange-Traded Funds Lower, Equity Futures Mixed Pre-Bell Tuesday as Investors Assess Impact of Government Shutdown

In premarket trading on Tuesday, major exchange-traded funds (ETFs) saw declines, with SPDR S&P 500 ETF down 0.3% and Invesco QQQ Trust down 0.5%. US stock futures were mixed, reflecting investor concerns over the government shutdown. The Small Business Optimism Index fell to 98.2 in October. EnGene Holdings shares surged 55% after positive trial results, while BigBear.ai rose 18% following a narrower Q3 loss. Energy ETFs gained, with iShares US Energy ETF up 2%. Crude oil prices increased by 0.6% to $60.46 per barrel.

EnGene shares are trading higher after the company reported additional Phase 2 LEGEND study data showing a 63% complete response rate and favorable safety profile for Detalimogene Voraplasmid.

enGene Reports 62% Complete Response Rate at 6 Months in Phase 2 Bladder Cancer Trial

enGene Holdings Inc. reported a 62% complete response rate at 6 months in its Phase 2 LEGEND trial for detalimogene voraplasmid in high-risk, BCG-unresponsive non-muscle invasive bladder cancer patients. The trial included 62 patients at 3 months and 37 at 6 months, showing favorable tolerability with mostly Grade 1 or 2 adverse events. enGene plans to submit a Biologics License Application in the second half of 2026, pending further FDA discussions and additional data. Future updates on the trial are anticipated in the same timeframe.

enGene Announces Preliminary Data Update from Pivotal LEGEND Trial in Bladder Cancer

enGene Holdings Inc. will host a conference call and webcast on November 11, 2025, at 8:00 a.m. ET to discuss preliminary data from the pivotal LEGEND trial, which evaluates its gene therapy candidate, detalimogene voraplasmid, in patients with high-risk, BCG-unresponsive non-muscle invasive bladder cancer. A slide deck will be available before the call, and a replay will be accessible on the company's website for one year.