Record mula sa primary source
Decision-gradeTopline na resulta
enGene: Ipinakita ng LEGEND pivotal cohort ang 54% CR, 43% 6-buwang CR para sa detalimogene
Ang press release ay nagbibigay ng updated interim efficacy at safety data mula sa 125-patient pivotal cohort ng Phase 2 LEGEND trial. Ipinapakita ng data ang 54% complete response rate sa anumang oras at 43% sa anim na buwan, na may mababang 3.2% progression rate sa muscle-invasive disease at favorable tolerability. Plano ng kumpanya ang karagdagang FDA engagement at potensyal na BLA filing update sa H2 2026.
Mahahalagang fact
- Na-file
- May 7, 2026, 11:11 AM
- Kaganapan
- Topline na resulta
- Direksyon
- Neutral
- Kumpanya
ENGNenGene- Pinagmulan
- SEC 8-K
- Kumpiyansa
- May source
- Kalendaryo
- Resulta ng trial · Hul 1, 2026 · Positibo
- CR sa 3 buwan
- 56% (n=62)
- CR sa 6 buwan
- 62% (n=37)
- Rate ng trae
- 42%
- CR anumang oras
- 63% (n=62)
- Mga pagkaantala sa dosis
- 1.6%
Sipi mula sa source
EX-99.1 2 d335486dex991.htm EX-99.1 EX-99.1 Exhibit 99.1 enGene Announces Updated Interim Results From LEGEND Pivotal Cohort 54% complete response (CR) rate at any time; 43% six-month CR rate Low rate of progression to muscle-invasive or higher disease (3.2%) Low percentage of patients experienced treatment-related adverse events (TRAEs) (55%), nearly all of which were mild Low percentage of patients experienced TRAEs leading to treatment interruption (2.4%) or discontinuation (2.4%) Kaplan-Meier estimate of 12-month CR rate is 25% enGene to host webcast to discuss results today, May 7, 2026, at 8:00 a.m. ET BOSTON & MONTREAL, May 7, 2026 – enGene Therapeutics Inc. (Nasdaq: ENGN or “enGene” or the “Company”), a clinical-stage, non-viral genetic medicines company, today reported a
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