Leerink Partners analysts slashed their sales forecast for enGene Therapeutics’ bladder cancer candidate after phase 2 data dented their belief that the biotech can match rivals, including Johnson & Johnson.
The data linked enGene’s detalimogene voraplasmid, a non-viral gene therapy, to a six-month complete response rate of 43% and an estimated 12-month duration of response of 25% in non-muscle invasive bladder cancer. The results fell well short of expectations and weakened enGene’s positioning versus assets including J&J’s Inlexzo and CG Oncology’s investigational cretostimogene grenadenorepvec, Leerink analysts said.
After assessing the implications of the readout, the analysts cut their unadjusted peak sales forecast for detalimogene from $1 billion to about $350 million. The analysts also slashed their price target from $19 to $2, resetting expectations just above the $1.72 level that the stock fell to in the wake of the readout.
The changes reflect the analysts’ belief that the new data “essentially foreclose the possibility of closing the efficacy gap” with CG and J&J in later updates from the phase 2 trial. The key debate is shifting from whether detalimogene is competitive to whether the gene therapy is approvable, the analysts said.
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The analysts think the FDA will see an approvable profile, only knocking their probability down from 70% to 60% in response to the data. But beyond that, they see detalimogene struggling commercially, penetrating 15% of the community opportunity and 5% of the academic setting. Previously, the analysts predicted the asset could penetrate 60% of the community market and 10% of the academic setting.
Convenience, practice economics, tolerability and community-based administration still favor enGene’s candidate, the analysts said. But with its rivals reporting six-month complete response rates of about 60%, the biotech faces an efficacy gap that has dampened expectations that it can carve out a sizable slice of a crowded market.
