Record mula sa primary source
MateryalNaisumite ang aplikasyon
enGene nagpaplano ng 12-buwang CR data at pre-BLA FDA meeting para sa detalimogene sa 2H 2026
The company will await 12-month complete response and durability data from LEGEND Cohort 1 before engaging the FDA in 2H 2026 to discuss initiating a BLA submission for detalimogene. Additional LEGEND cohorts (2a, 2b, 3) have been paused as part of a 50% workforce reduction to conserve cash for the planned BLA and pre-commercial activities.
Mahahalagang fact
- Na-file
- Hun 15, 2026, 01:14 PM
- Kaganapan
- Naisumite ang aplikasyon
- Direksyon
- Neutral
- Kumpanya
ENGNenGene- Pinagmulan
- SEC 8-K
- Kumpiyansa
- May source
- CR anumang oras
- 54% (95% CI: 45%, 63%)
- Rate ng pag-unlad
- 3.2%
- Pagkaantala dahil sa trae
- 2.4%
- Pagtigil dahil sa trae
- 2.4%
Sipi mula sa source
EX-99.1 2 engn-ex99_1.htm EX-99.1 EX-99.1 Exhibit 99.1 enGene Reports Second Quarter 2026 Financial Results and Provides Business Update 12-month complete response data from LEGEND pivotal cohort and subsequent FDA engagement planned for 2H 2026 Initiation of Biologics License Application (BLA) filing for detalimogene planned for 2H 2026 First patients enrolled in surfactant plus detalimogene cohort Approximately 50% reduction in force to streamline operations and preserve cash to focus on BLA and precommercial activities Well capitalized with cash, cash equivalents and marketable securities of $285 million BOSTON & MONTREAL, June 15, 2026 – enGene Therapeutics Inc. (Nasdaq: ENGN, “enGene” or the “Company”), a clinical-stage, non-viral genetic medicines company today announced its fina
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