enGene plans 12-mo CR data & pre-BLA FDA meeting for detalimogene in 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.

Key facts

Filed: Jun 15, 2026, 01:14 PM
Event: Application submitted
Direction: Neutral
Company: ENGNenGene
Asset: detalimogene voraplasmid
Source: SEC 8-K
Confidence: Sourced
CR any time: 54% (95% CI: 45%, 63%)
progression rate: 3.2%
trae interruption: 2.4%
trae discontinuation: 2.4%

Source excerpt

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 financial results for the second quarter ended April 30, 2026, and provided clinical and corporate updates. “Feedback from the urology community on the emerging detalimogene without surfactant profile, presented at the AUA meeting in May, supports our plan to await mature durability data in the second half of 2026 and meet with the FDA about initiating a BLA submission for detalimogene before year end,” said Ron Cooper, President and Chief Executive Officer, enGene. Mr. Cooper continued, “We are also encouraged by the interest in the detalimogene surfactant bladder rinse study from the medical community. With patients already enrolled, we are optimistic about the potential to further enhance eff

SEC 8-K