enGene Therapeutics Inc. ENGN
enGene Therapeutics Inc. (Nasdaq: ENGN) is an oncology drug developer. Its lead program, Detalimogene voraplasmid (EG-70), is in Phase 2 for BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ. Its next catalyst on record is Detalimogene voraplasmid: Reevaluate additional LEGEND cohorts after FDA discussion (Q4 2026).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: Detalimogene voraplasmid — Reevaluate additional LEGEND cohorts after FDA discussion (Q4 2026). 3 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| Detalimogene voraplasmid | BCG-unresponsive high-risk NMIBC with CIS (LEGEND Phase 2 Cohort 1, pivotal; enrollment complete, 125 pts) | gene therapy | Phase 2 |
| Detalimogene voraplasmid + polidocanol surfactant rinse | NMIBC (new LEGEND cohort, up to 80 pts, first patients enrolled) | gene therapy | Phase 2 |
| Detalimogene voraplasmid | BCG-naive and BCG-exposed high-risk NMIBC with CIS (Cohorts 2a/2b) and papillary-only BCG-unresponsive (Cohort 3); enrollment stopped to conserve cash | gene therapy | Phase 2 |
Recent results and decisions
- Jul 17, 2026positive Pivotal cohort 1 interim (n=125, data as of 21 Apr 2026): 54% any-time complete response, primary endpoint; 6-month CR 43.0%, 12-month CR 13.3% (n=98).
54% CR Anytime (Primary Endpoint), With Low Rate of Progression to Advanced Disease
Filing - Jun 15, 2026started First patients enrolled in the LEGEND detalimogene plus surfactant bladder rinse cohort, which may enroll up to 80 patients.
The first patients have been enrolled in the surfactant cohort, and the Company may enroll up to 80 patients in this global cohort.
Filing - Jun 15, 2026discontinued Enrollment stopped in LEGEND Cohorts 2a, 2b and 3 to conserve cash, alongside a ~50% workforce reduction.
As part of cash conservation efforts, the Company has stopped enrollment in these additional cohorts and plans to reevaluate its strategy for them following discussion with the FDA in 2H 2026.
Filing
4 more on record.
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 2 oncology companies
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- Obsidian Therapeutics, Inc. OBX
- Puma Biotechnology, Inc. PBYI
- Fulgent Genetics, Inc. FLGT
- Delcath Systems, Inc. DCTH
- Unknown Unknown
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.