Catalysts / ENGN
Upcoming FDA decisions and readouts we track for enGene Holdings, each with the filing that announced it.
FreeBioList tracks 2 upcoming catalysts for enGene Holdings (ENGN, listed on Nasdaq). Both concern Detalimogene voraplasmid (Non-muscle invasive bladder cancer).
First on the list: the Phase 2 readout for Detalimogene voraplasmid (Non-muscle invasive bladder cancer), guided by the company to H2 2026. By stage, the upcoming rows are 1 Phase 2 readout and 1 Regulatory submission.
Both rows link to SEC filings (8-K or 6-K). Both have been verified by a person reading the filing itself, most recently on 12 Sep 2026. The methodology page explains each status.
Background reading: Clinical trial phases explained: Phase 1 to Phase 4; NDA vs BLA: the two kinds of US drug application.
| Company ▾ | Drug ▾ | Effect / indication | Next catalyst ▾ | Phase / type ▾ | Status ▾ | Source | Options |
|---|---|---|---|---|---|---|---|
| enGene Holdings ENGN · Nasdaq | Detalimogene voraplasmid | Non-muscle invasive bladder cancer | H2 2026 company guidance |
Phase 2 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| enGene Holdings ENGN · Nasdaq | Detalimogene voraplasmid | Non-muscle invasive bladder cancer | H2 2026 company guidance |
Regulatory submission | Verified | 8-K exhibit 99.1 ↗ | Yes |
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