$ENGN News
Last published 5h ago
- 5h agoENGNenGene to Initiate a BLA Submission for Detalimogene by Year End and Reports New Data from LEGEND Trial Pivotal Cohort 1 in BCG-Unresponsive NMIBCBusiness WireBOSTON & MONTREAL--(BUSINESS WIRE)--enGene Therapeutics Inc. (Nasdaq: ENGN, “enGene” or the “Company”), a clinical-stage, non-viral genetic medicines company, today announced updated results from the pivotal Cohort 1 of its ongoing, Phase 2 LEGEND trial of detalimogene voraplasmid (also known as detalimogene). Data from Cohort 1, which enrolled 125 patients with high-risk, Bacillus Calmette-Guérin ...
- 5h agoENGNenGene Appoints Key Executives in Anticipation of Upcoming Regulatory and Commercial MilestonesBusiness WireBOSTON & MONTREAL--(BUSINESS WIRE)--enGene Therapeutics Inc. (Nasdaq: ENGN) (“enGene” or the “Company”), a clinical-stage, non-viral genetic medicines company, today announced the appointments of Erik T. Goluboff, MD, MBA as Chief Medical Officer and Jason Duncan as Chief Legal and Administrative Officer, effective November 9, 2026. enGene's lead investigational candidate, detalimogene voraplasmid ...
- 4w agoENGNenGene to Host KOL Webinar on October 15, 2026Business WireCommunity Key Opinion Leaders (KOLs) to present on real-world clinical decision making in high-risk non-muscle invasive bladder cancer (NMIBC) Additional discussion to focus on preclinical data supporting
- 1mo agoENGNMorgan Stanley 24th Annual Global Healthcare Conference - ENGENE THERAPEUTICS INCEarnings Call TranscriptsAll right, good morning, everyone, and welcome to the 2026 Morgan Stanley Global Healthcare Conference. I'm Judah Fromer, one of the mid-camp biotech analysts here. We're very excited to have Ron Cooper from NGENE kickin
- 2mo agoENGNenGene Reports Third Quarter 2026 Financial Results and Provides Business UpdateBusiness WireData update on key regulatory endpoints, complete response (CR) at any time and maturing durability, as well as landmark CR rates from LEGEND's pivotal cohort planned for 4Q 2026 Pre-Biologics License Application
- 2mo agoENGNenGene to Participate in Upcoming Investor ConferencesBusiness WireenGene Therapeutics Inc. (NASDAQ:ENGN, "enGene" or the "Company")), a clinical-stage, non-viral genetic medicines company today announced that management will participate in the following investor
- 3mo agoENGNenGene to Host Virtual KOL Event to Discuss Emerging Non-Muscle Invasive Bladder Cancer (NMIBC) Market Insights, on August 11, 2026Business WireenGene Therapeutics Inc. (NASDAQ:ENGN, "enGene" or the "Company")), a clinical-stage, non-viral genetic medicines company, today announced that it will host a virtual key opinion leader (KOL) event on
- 3mo agoENGNenGene Focuses Board to Support Planned Upcoming Regulatory and Commercial MilestonesBusiness WireMichael Heffernan assumes the role of Chairman of the Board Dr. Richard Glickman to step down Pre-Biologics License Application (BLA) meeting with the FDA planned for 2H 2026 Initiation of BLA submission for
- 3mo agoENGNGERNRectify Pharmaceuticals Announces Appointment of Constantine Chinoporos as Executive ChairmanGlobeNewswireThe appointment comes as Rectify transitions into a clinical-stage company following the recent initiation of the Phase 1 study of RTY-406, its lead program for hepatobiliary diseases.Rectify is developing oral
- 4mo agoENGNenGene Reports Second Quarter 2026 Financial Results and Provides Business UpdateBusiness Wire12-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
- 6mo agoENGNenGene Announces Updated Interim Results From LEGEND Pivotal CohortBusiness Wire54% 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
- 7mo agoENGNENGNWenGene Announces Name Change to enGene Therapeutics Inc.Business WireName change reflects transition towards potential commercial organization in 2027 Planned Biologics License Application (BLA) submission for detalimogene in 2H 2026 enGene Therapeutics Inc. (formerly, enGene
- 7mo agoONCYGILDENGNTCRX+1Combination Therapies Reshape Oncology: A $748B Market Shifts Standard of CarePR NewswireUSANewsGroup.com News Commentary — The global oncology market is valued at $279.98 billion in 2026 and is on track to reach $748.17 billion by...
- 8mo agoENGNHTGCenGene Reports First Quarter 2026 Financial Results and Provides Business UpdateBusiness WireLEGEND pivotal cohort update planned for a spring 2026 medical conference 12-month complete response data from LEGEND pivotal cohort expected in 2H 2026 Biologics License Application (BLA) submission for
- 8mo agoENGNenGene to Participate in Upcoming Investor ConferencesBusiness WireenGene Holdings Inc. (NASDAQ:ENGN), a clinical-stage, non-viral genetic medicines company, today announced that management will participate in the following investor conferences: Oppenheimer 36th Annual Healthcare
- 9mo agoENGNenGene to Participate in the Guggenheim Emerging Outlook: Biotech Summit 2026Business WireenGene Holdings Inc. (NASDAQ:ENGN), a clinical-stage, non-viral genetic medicines company, today announced that Ron Cooper, President and Chief Executive Officer, will participate in a fireside chat at the Guggenheim
- 10mo agoENGNenGene Reports Full Year 2025 Financial Results and Provides Business UpdateBusiness WireCompleted enrollment in LEGEND's pivotal cohort with 125 patients in high-risk, BCG-unresponsive NMIBC with carcinoma in situ Reported preliminary 6-month complete response rate (62%) in pivotal cohort patients
- 11mo agoENGNenGene's Detalimogene Selected for FDA Manufacturing Pilot Program to Support Manufacturing ReadinessBusiness WireenGene one of nine companies awarded CDRP per year Program aims to support CMC development of products with expedited clinical development timeframes and provide patients with earlier access to these
- 11mo agoENGNenGene to Present at the Piper Sandler 37th Annual Healthcare ConferenceBusiness WireenGene Holdings Inc. (NASDAQ:ENGN), a clinical-stage, non-viral genetic medicines company, today announced that Alex Nichols, Ph.D., Chief Strategy and Operations Officer, will present at the Piper Sandler 37th Annual
- 12mo agoENGNenGene Announces Proposed Public Offering of Common SharesBusiness WireenGene Holdings Inc. (NASDAQ:ENGN, "enGene" or the "Company")), a clinical-stage, non-viral genetic medicines company, today announced that it has commenced an underwritten public offering of its common shares. All
- 1y agoENGNDetalimogene Demonstrates Improved Complete Response Rate of 62% at 6 MonthsBusiness WireLow 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
- 1y agoENGNenGene to Host Conference Call to Provide Update on Pivotal Cohort of LEGEND TrialBusiness WireenGene 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
- 1y agoENGNenGene to Participate in Upcoming Investor ConferencesBusiness WireenGene Holdings Inc. (NASDAQ:ENGN), a clinical-stage, non-viral genetic medicines company, today announced that management will participate in the following investor conferences in November: Guggenheim 2nd Annual
- 1y agoENGNenGene Named a BioSpace 2026 Best Places to Work WinnerBusiness WireenGene selected for its innovation in advancing non-viral genetic medicines and fostering a culture of collaboration and purpose Selection follows BIOTECanada's 2025 Biotech Company of the Year award enGene Holdings
- 1y agoGTBPIMABENGNONCO+1Novel Cancer Platforms Converge as Clinical Data Reshapes Treatment ParadigmsPR NewswireEquity InsiderNews Commentary – Major pharmaceutical companies presenting at the European Society for Medical Oncology Congress October 17-21[1] are...
- 1y agoENGNenGene Reports Inducement Grants Under NASDAQ Listing Rule 5635(c)(4)Business WireenGene Holdings Inc. (NASDAQ:ENGN, "enGene" or the "Company")), a clinical-stage, non-viral genetic medicines company, today reported the grant of inducement equity awards to four newly-hired employees, including
- 1y agoENGNenGene Appoints Hussein Sweiti, M.D., MSc, as Chief Medical OfficerBusiness WireBladder cancer development leader who helped drive recent FDA product approval in NMIBC joins to lead research and development strategy Appointment strengthens enGene's clinical development and regulatory
- 1y agoENGNenGene Reports Third Quarter 2025 Financial Results and Provides Business UpdateBusiness WireAchieved 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
- 1y agoENGNEnGene Holdings Inc. (ENGN) Presents At Morgan Stanley 23rd Annual Global Healthcare Conference TranscriptEarnings Call Transcripts
- 1y agoENGNenGene Achieves Target Enrollment Milestone for LEGEND Trial Pivotal CohortBusiness WireTarget enrollment of 100 patients with high-risk, BCG-unresponsive NMIBC with CIS achieved enGene plans to provide an update from LEGEND's pivotal cohort in 4Q 2025 Biologic License Application (BLA) submission
- 1y agoENGNenGene to Participate in Upcoming Investor ConferencesBusiness WireenGene Holdings Inc. (NASDAQ:ENGN), a clinical-stage, non-viral gene therapy company, today announced that management will participate in the following investor conferences in September: 2025 Wells Fargo Healthcare
- 1y agoENGNenGene Reports Inducement Grants Under NASDAQ Listing Rule 5635(c)(4)Business WireenGene Holdings Inc. (NASDAQ:ENGN, "enGene" or the "Company")), a clinical-stage, non-viral gene-based immunotherapy company, today reported the grant of inducement equity awards to three newly-hired employees, with a
- 1y agoENGNenGene Announces Board and Leadership Appointments to Support Commercial ReadinessBusiness WirePhilip Astley-Sparke, William Grossman and Michael Heffernan join the Board Management promotions strengthen clinical and regulatory operations Matthew Boyd named Chief Regulatory Officer, Jill Buck Chief
- 1y agoENGNFDA Grants RMAT Designation for enGene's Detalimogene, Enabling Potential for Expedited Review in High-Risk, Non-Muscle Invasive Bladder CancerBusiness WireRegenerative Medicine Advanced Therapy (RMAT) designation provides access to accelerated development tools Designation recognizes the potential of detalimogene to address significant unmet need enGene Holdings Inc.
- 1y agoENGNenGene Reports Inducement Grants Under NASDAQ Listing Rule 5635(c)(4)Business WireenGene Holdings Inc. (NASDAQ:ENGN, "enGene" or the "Company")), a clinical-stage, non-viral genetic medicines company, today reported the grant of inducement equity awards to four newly-hired employees, including Amy
- 1y agoENGNenGene Reports Second Quarter 2025 Financial Results and Provides Business UpdateBusiness WireAdditional 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
- 1y agoENGNenGene Announces the Resignation of its Chief Medical OfficerBusiness WireenGene Holdings Inc. (NASDAQ:ENGN), a clinical-stage, non-viral genetic medicines company, announced today that Dr. Raj Pruthi resigned from his role as Chief Medical Officer on June 3, 2025. Dr. Pruthi's resignation as
- 1y agoENGNenGene to Present at the Jefferies Global Healthcare ConferenceBusiness WireenGene Holdings Inc. (NASDAQ:ENGN), a clinical-stage, non-viral genetic medicines company, today announced that Ron Cooper, Chief Executive Officer, will present at the Jefferies Global Healthcare Conference in New York
- 1y agoENGNenGene Names Amy Pott as Chief Global Commercialization OfficerBusiness WireenGene Holdings Inc. (NASDAQ:ENGN), a clinical-stage, non-viral genetic medicines company, today announced the appointment of Amy Pott as Chief Global Commercialization Officer. In this role, Ms. Pott will serve as the
- 1y agoENGNenGene to Participate in Upcoming Investor ConferencesBusiness WireenGene Holdings Inc. (NASDAQ:ENGN), a clinical-stage, non-viral genetic medicines company, today announced that management will present at upcoming investor conferences in May 2025. Details of the conferences are
- 1y agoENGNenGene Reports Inducement Grants Under NASDAQ Listing Rule 5635(c)(4)Business WireenGene Holdings Inc. (NASDAQ:ENGN, "enGene" or the "Company")), a clinical-stage, non-viral genetic medicines company, today reported the grant of inducement equity awards to seven newly-hired employees, with a grant
- 1y agoENGNenGene to Present at the Stifel 2025 Virtual Targeted Oncology ForumBusiness WireenGene Holdings Inc. (NASDAQ:ENGN), a clinical-stage, non-viral genetic medicines company, today announced that Ron Cooper, Chief Executive Officer, will present at the Stifel 2025 Virtual Targeted Oncology Forum, on
- 1y agoENGNenGene Reports First Quarter 2025 Financial Results and Provides Business UpdateBusiness WireAdditional 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
- 1y agoENGNenGene to Participate in the Leerink Partners Global Healthcare ConferenceBusiness WireenGene Holdings Inc. (NASDAQ:ENGN), a clinical-stage, non-viral genetic medicines company, today announced that Ron Cooper, Chief Executive Officer, will participate in a fireside chat at the Leerink Partners Global
- 1y agoENGNenGene to Present at the Oppenheimer 35th Annual Healthcare Life Sciences ConferenceBusiness WireenGene Holdings Inc. (NASDAQ:ENGN), 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
- 1y agoENGNenGene Reports Inducement Grants Under NASDAQ Listing Rule 5635(c)(4)Business WireenGene Holdings Inc. (NASDAQ:ENGN, "enGene" or the "Company")), a clinical-stage genetic medicines company whose non-viral lead investigational product detalimogene voraplasmid, (also known as detalimogene, and
- 1y agoENGNenGene to Present Three Posters at the 2025 ASCO Genitourinary Cancers Symposium (ASCO GU) Highlighting the Ongoing Clinical Development of Detalimogene Voraplasmid for the Treatment of Non-Muscle Invasive Bladder Cancer (NMIBC)Business WireDetalimogene voraplasmid is a novel, investigational, pivotal-stage, non-viral genetic medicine designed to mitigate systemic risks and deliver durable efficacy for patients with high-risk NMIBC, including Bacillus
- 1y agoENGNenGene Reports Inducement Grants Under NASDAQ Listing Rule 5635(c)(4)Business WireenGene Holdings Inc. (NASDAQ:ENGN, "enGene" or the "Company")), a clinical-stage genetic medicines company whose non-viral lead investigational product detalimogene voraplasmid, (also known as detalimogene, and
- 1y agoENGNenGene Reports Full Year 2024 Financial Results and Provides a Business UpdateBusiness WireBLA 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
- 1y agoENGNenGene to Participate in Upcoming Investor ConferencesBusiness WireenGene Holdings Inc. (NASDAQ:ENGN), 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