Raymond James Downgrades Engene Holdings Inc. (ENGN) to Outperform

Raymond James analyst Sean McCutcheon downgraded Engene Holdings Inc. (NASDAQ: ENGN) from Strong Buy to Outperform with a price target of $4.00 (from $27.00).

The analyst comments: “Results came in far below our expectations and patients enrolled into the study after the last update (since ~October 2025) dramatically underperformed. The CR rate at any time for those in the post-protocol change chart when from 63% (n=63) to 39% (n=32) in those enrolled before and after October 2025. All of these patients were enrolled following what we saw as constructive updates to the study protocol aligning LEGEND with other comparable studies in the space. Management was not able to explain the reason for the dramatic drop-off in efficacy, though did note a low conversion of 3 mo non-CR in to CR (14%) and a number of patients that discontinued rather than receive re-induction. We need to see clarity on the decrement in efficacy to be more constructive on the program.

While the full data are disappointing, we do think there is still a chance at approval, as the results fall in line with Adstiladrin. We anticipate the single arm approval pathway to remain intact for enGene given the clear precedent for single arm approvals in this space. We await management commentary on feedback from FDA as it relates to filing a BLA for detalimogene by year-end based on the current LEGEND results. We expect this commentary during 2H26. Until then, we anticipate skepticism from the investment community on whether these data constitute enough evidence for approval.”

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 $1.72 yesterday.

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