What does the enrollment rate and trial design suggest about the timeline for data read‑outs and potential regulatory filing compared to other NMIBC gene‑therapy competitors?

Enrollment speed and trial design as a timeline cue

enGene’s announcement that the pivotal Cohort 1 of the Phase 2 LEGEND trial has already hit its 100‑patient enrollment target is unusually fast for a NMIBC gene‑therapy study. The trial is open‑label, multi‑cohort and enrolls patients with high‑risk, non‑muscle‑invasive bladder cancer—a population that is relatively abundant and well‑characterized, allowing sites to screen and randomize quickly. Because the pivotal cohort is now fully accrued, the company can begin the planned safety‑follow‑up and efficacy read‑out windows within the next 3‑6 months. With a typical Phase 2 read‑out window of 12‑18 months after the last patient‑first‑dose, investors can reasonably expect the first efficacy data by Q4 2025 and a potential regulatory filing (e.g., a BLA or FDA‑type “fast‑track” submission) in H1 2026 if the data are compelling.

Relative position versus peers

Most NMIBC gene‑therapy rivals—such as ImmunityBio’s N‑803/T‑cell platform, Caladrius’s Ad‑CTL4, and Ferring’s oncolytic vectors—have either larger, staggered enrollment targets (150‑200 pts) or are still in early‑phase, single‑cohort studies that won’t finish enrollment until 2026‑2027. Their timelines consequently push read‑outs and filing dates into 2027 or later. enGene’s aggressive enrollment and its rolling‑cohort design therefore compress the data‑generation horizon, giving it a potential 12‑18‑month lead on competitors. From a trading perspective, the near‑term catalyst (first read‑out) could drive a short‑to‑mid‑term upside if data look favorable, while the earlier filing window creates a “regulatory‑event tail” that may attract speculative positioning ahead of a possible FDA decision. Conversely, any delay in safety signals or efficacy read‑outs would disproportionately hurt enGene because the market has priced in this speed advantage relative to peers.