ENGN - Earnings announcements

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 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 pr

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 enGene Therapeutics Inc. (NASDAQ:ENGN), a clinical-stage, non-viral genetic medicines company, today reported additional interim results from the pivotal cohort of its ongoing, Phase 2 LEGEND t

Low rates of treatment-related adverse events (42%) and dose interruptions (1.6%) Emerging detalimogene profile supports potential first line use in patients with high-risk, BCG-unresponsive non-muscle invasive bladder cancer with CIS LEGEND trial pivotal cohort completed enrollment with 125 patients, exceeding target enGene to host conference call and webcast at 8:00 a.m. ET enGene Holdings Inc. (NASDAQ:ENGN), a clinical-stage, non-viral genetic medicines company, today reported additional preliminary data from the pivotal cohort of its ongoing, Phase 2 LEGEND trial of detalimogene voraplasmid (also known as detalimogene and previously EG-70) in high-risk, Bacillus Calmette-Guérin

enGene Holdings Inc. (NASDAQ:ENGN), a clinical-stage, non-viral genetic medicines company, today announced that it will host a conference call and webcast tomorrow, November 11, 2025, at 8:00 a.m. ET to discuss new preliminary data from its pivotal cohort in the ongoing LEGEND trial of its novel, non-viral gene therapy candidate, detalimogene voraplasmid (also known as detalimogene, and previously EG-70) for patients with high-risk, Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer with carcinoma in situ. The live call can be accessed by registering as a participant here. Upon registration, participants will receive conference dial-in information. A link to th

Achieved target enrollment milestone for LEGEND trial pivotal cohort in high-risk BCG unresponsive NMIBC with carcinoma in situ LEGEND's pivotal cohort data update planned for 4Q 2025 Detalimogene granted Regenerative Medicine Advanced Therapy (RMAT) designation by FDA Biologic License Application (BLA) submission planned for 2H 2026 Cash and marketable securities of $224.9 million expected to provide runway into 2027 enGene Holdings Inc. (NASDAQ:ENGN, "enGene" or the "Company")), a clinical-stage, non-viral gene therapy company, today announced its financial results for the third quarter ended July 31, 2025, and provided a business update. "Reaching target enrollment in LEGEND'

Additional preliminary data from ongoing LEGEND study of detalimogene in pivotal cohort of BCG-unresponsive NMIBC with CIS anticipated in 2H 2025 Biologics License Application (BLA) filing planned for mid-2026 remains on track EMA Scientific Advice completed; Indicated data could be suitable for a Contingent Marketing Authorization Application Cash and marketable securities of $251.5 million expected to provide runway into 2027 enGene Holdings Inc. (NASDAQ:ENGN, or "enGene" or the "Company")), a clinical-stage, non-viral genetic medicines company, today announced its financial results for the second quarter ended April 30, 2025, and provided a business update. "We have seen strong

Additional preliminary data from ongoing LEGEND study of detalimogene in BCG-unresponsive NMIBC with CIS, including pivotal cohort, anticipated in 2H 2025 Biologics License Application (BLA) filing planned for mid-2026 remains on track Cash and marketable securities of $272.8 million expected to provide runway into 2027 enGene Holdings Inc. (NASDAQ:ENGN, or "enGene" or the "Company")), a clinical-stage, non-viral genetic medicines company, today announced its financial results for the first quarter ended January 31, 2025, and provided a business update. "With the expansion of LEGEND study sites into Europe and Asia, enrollment in our pivotal cohort continues to track in-line with our pl

BLA filing for detalimogene in BCG-unresponsive NMIBC with CIS on track for mid-2026 All cohorts of the Phase 2 LEGEND study now recruiting under updated protocol Additional preliminary data from pivotal cohort anticipated in 2H 2025 Cash, cash equivalents and marketable securities of $297.9 million provide runway into 2027 enGene Holdings Inc. (NASDAQ:ENGN, or "enGene" or the "Company")), a clinical-stage genetic medicines company whose non-viral lead investigational product detalimogene voraplasmid, (also known as detalimogene, and previously EG-70), is in an ongoing pivotal study in patients with high-risk, Bacillus Calmette-Guérin (BCG)-unresponsive, non-muscle invasive bladder

Data from pivotal cohort demonstrate compelling clinical activity, consistent with Phase 1 results Favorable tolerability profile with no drug-related discontinuations Detalimogene's profile to date supports its potential as a foundational therapy for NMIBC enGene to host a conference call to discuss preliminary data today at 8:00 a.m. ET enGene Holdings Inc. (NASDAQ:ENGN), is a clinical-stage genetic medicines company whose non-viral lead investigational product detalimogene voraplasmid (also known as detalimogene, and previously EG-70) is in an ongoing pivotal study in patients with high-risk, Bacillus Calmette-Guérin (BCG)-unresponsive, non-muscle invasive bladder cancer (NMIBC) with

Company remains on track to report preliminary LEGEND data in September 2024 Cash and cash equivalents of $257.7 million provide runway into 2027 enGene Holdings Inc. (NASDAQ:ENGN, or "enGene" or the "Company"))), a clinical-stage genetic medicines company whose non-viral lead investigational product detalimogene voraplasmid, (also known as detalimogene, and previously EG-70), is in an ongoing pivotal study in patients with high-risk, Bacillus Calmette-Guérin (BCG)-unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (Cis), announced its financial results for the third quarter ended July 31, 2024 and provided a business update. "Detalimogene was designed to be

Company announces plans for initial indication expansion for EG-70 into high-risk papillary-only NMIBC enGene Holdings Inc. (NASDAQ:ENGN, "enGene" or the "Company"))), a clinical-stage genetic medicines company whose non-viral, intravesical lead product candidate, EG-70, is in a pivotal study for BCG-unresponsive high-risk non-muscle invasive bladder cancer (NMIBC), today announced its financial results for the second quarter ended April 30, 2024, and provided a business update. "Our $200 million private placement in February positioned us well to execute our primary strategy of broadly developing EG-70 to be a patient- and practice-friendly option across a multitude of potential bladde

Pivotal phase 2 LEGEND study of EG-70 in BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) remains on track with interim data anticipated in mid-2024 Closed a $200 million oversubscribed private financing, expected to extend cash runway into 2027 BOSTON and MONTREAL, March 11, 2024 /CNW/ - enGene Holdings Inc. (NASDAQ:ENGN, enGene", or the ", Company", ))), a clinical-stage genetic medicines company whose non-viral, intravesical lead product candidate, EG-70, is in a pivotal study for BCG-unresponsive non-muscle invasive bladder cancer (NMIBC), today announced its financial results for the first quarter ended January 31, 2024.

Pivotal phase 2 LEGEND study of EG-70 in BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) remains on track with interim data anticipated in mid-2024 Closed a $200 million oversubscribed private financing, expected to extend cash runway into 2027 BOSTON and MONTREAL, March 11, 2024 /PRNewswire/ - enGene Holdings Inc. (NASDAQ:ENGN, enGene", or the ", Company", ))), a clinical-stage genetic medicines company whose non-viral, intravesical lead product candidate, EG-70, is in a pivotal study for BCG-unresponsive non-muscle invasive bladder cancer (NMIBC), today announced its financial results for the first quarter ended January 31, 2024.

Achieved primary and secondary endpoints in Phase 1 portion of LEGEND study in non-muscle invasive bladder cancer (NIMBC); pivotal portion underway with interim data expected mid this year Completed a reverse merger transaction with Forbion European Acquisition Corp (FEAC), launched as a public company on November 1, 2023, and completed an upsized PIPE financing Combined transactions resulted in net proceeds of approximately $109 million Closed an expanded $50M debt facility with Hercules Capital in December 2023; extends cash runway into Q2 2025 BOSTON and MONTREAL, Jan. 29, 2024 /PRNewswire/ - enGene Holdings Inc. (NASDAQ:ENGN) (or "enGene" or the "Company"), a clinical-stage genetic medic