H.C. Wainwright Reiterates Buy Rating on Engene Holdings Inc. (ENGN)

H.C. Wainwright analyst Andres Maldonado reiterated a Buy rating and $25.00 price target on Engene Holdings Inc. (NASDAQ: ENGN).

The analyst commented: "enGene’s detalimogene has been selected for the Chemistry, Manufacturing, and Controls Development and Readiness Pilot (CDRP) program, which aims to support CMC development with accelerated clinical development timeframes. Building upon stacked RMAT and Fast Track designations from the FDA, CDRP designation – exclusively awarded to nine companies per year – signals continued clinical and regulatory alignment that ensures CMC readiness for filing and commercialization. Commercial readiness remains critical as detalimogene’s straightforward storage, preparation, and administration may allow for rapid uptake across urology practices, particularly in community settings. This update is timely given our recent virtual KOL discussion which emphasized the potential for detalimogene to capture meaningful market share given its differentiated operational and economic value with off-the-shelf readiness, ease of use, and seamless workflow integration (see note here). The company maintains that detalimogene has already been manufactured at commercial scale and sees CDRP as providing additional FDA CMC interactions ahead of BLA filing anticipated in 2H26. Collectively, these FDA designations will compress clinical timelines while simultaneously supporting commercial readiness, positioning detalimogene for a successful launch if approved. In our view, this additional FDA programmatic backing further de-risks detalimogene’s launch trajectory by ensuring that enGene can deliver product inventory levels that meet high demand across urology centers. We reiterate our Buy rating and $25 PT."

For an analyst ratings summary and ratings history on Engene Holdings Inc. click here. For more ratings news on Engene Holdings Inc. click here.

Shares of Engene Holdings Inc. closed at $7.86 yesterday.

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