enGene (ENGN) FDA Approvals $1.73 +0.12 (+7.45%) Closing price 04:00 PM EasternExtended Trading$1.68 -0.05 (-2.83%) As of 06:18 PM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Massive. Learn more. Add Compare Share Share FDA Events Stock AnalysisAnalyst ForecastsChartCompetitorsEarningsFDA EventsHeadlinesInsider TradesOwnershipSEC FilingsShort InterestTrendsBuy This Stock enGene's Drug in the FDA Approval ProcessThis section highlights FDA-related milestones and regulatory updates for drugs developed by enGene (ENGN). Over the past two years, enGene has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as EG-70. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. EG-70 FDA Regulatory Timeline and Events EG-70 is a drug developed by enGene for the following indication: for Expedited Review in High-Risk, Non-Muscle Invasive Bladder Cancer. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy. Provided Update - December 2,2025Provided Update Drug: EG-70Announced Date: December 2, 2025Indication: for Expedited Review in High-Risk, Non-Muscle Invasive Bladder CancerAnnouncementenGene Holdings Inc. announced that the U.S. Food and Drug Administration (FDA) has selected detalimogene voraplasmid (also known as detalimogene and previously EG-70) to participate in the Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) Program.Detalimogene is a novel, investigational, non-viral gene therapy for patients with high-risk, non-muscle invasive bladder cancer (NMIBC).AI SummaryenGene Holdings announced that the U.S. Food and Drug Administration selected its investigational non‑viral gene therapy, detalimogene voraplasmid (detalimogene), to join the CMC Development and Readiness Pilot (CDRP) Program. Detalimogene is being developed as an intravesical treatment for patients with high‑risk non‑muscle invasive bladder cancer (NMIBC). The CDRP Program supports chemistry, manufacturing, and controls (CMC) development for products with compressed clinical timelines and aims to help patients gain earlier access to promising therapies. enGene is one of nine companies chosen for the program each year. Because detalimogene has already been manufactured at commercial scale, participation in CDRP will provide additional, structured FDA CMC interactions to help ensure manufacturing readiness ahead of a potential Biologics License Application (BLA) submission in the second half of 2026. enGene says the CDRP engagement should strengthen CMC planning and align manufacturing with regulatory expectations as clinical development proceeds toward possible approval. Read AnnouncementPreliminary Data - November 11,2025Preliminary Data Phase 2Drug: EG-70Announced Date: November 11, 2025Indication: for Expedited Review in High-Risk, Non-Muscle Invasive Bladder CancerAnnouncementenGene Holdings Inc. 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 (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) patients with carcinoma in situ (CIS) with or without concomitant papillary disease.AI SummaryenGene reported additional preliminary data from the pivotal cohort of its Phase 2 LEGEND trial of detalimogene voraplasmid in high‑risk, BCG‑unresponsive non‑muscle invasive bladder cancer with carcinoma in situ. The pivotal cohort completed enrollment at 125 patients, exceeding the target. An analysis of patients treated under an amended protocol (62 patients with 3‑month data; 37 with 6‑month data) showed a 63% complete response (CR) rate at any time, 56% CR at 3 months, and 62% CR at 6 months (including four patients who converted to CR after reinduction). All five patients assessed at 9 months had a CR. Safety among 125 patients was favorable: 42% experienced a treatment‑related adverse event, mostly Grade 1–2; three patients had Grade 3 events. Dose interruptions occurred in 1.6% and discontinuations in 0.8%. Common side effects included fatigue, dysuria, bladder spasm, urgency and pollakiuria. Other LEGEND cohorts continue to enroll, and enGene plans to use these results to support a planned Biologics License Application in the second half of 2026.Read AnnouncementEnrollment Update - September 3,2025Enrollment Update Phase 2Drug: EG-70Announced Date: September 3, 2025Indication: for Expedited Review in High-Risk, Non-Muscle Invasive Bladder CancerAnnouncementenGene Holdings Inc. announced it has achieved its target enrollment milestone of 100 patients for the pivotal cohort of its ongoing, open-label, multi-cohort Phase 2 LEGEND trial of detalimogene voraplasmid ("detalimogene" and previously EG-70) in patients with high-risk, non-muscle invasive bladder cancer (NMIBC).AI SummaryenGene Holdings Inc. announced it has enrolled 100 patients in the pivotal cohort of its Phase 2 LEGEND trial studying detalimogene voraplasmid in high-risk, non-muscle invasive bladder cancer (NMIBC) patients with carcinoma in situ (CIS), with or without papillary disease. The open-label, multi-cohort study remains open to screening and may overenroll beyond the initial target. The company expects to share data from LEGEND’s pivotal cohort in the fourth quarter of 2025 and plans to submit a Biologics License Application in the second half of 2026. Overenrollment could lead to a slight shift in that timeline, offering more robust safety and efficacy insights. “Reaching our enrollment goal for detalimogene in LEGEND’s pivotal cohort marks a key milestone,” said Ron Cooper, CEO of enGene. “It brings us closer to delivering the first non-viral gene therapy option that balances strong anti-tumor activity with safety and ease of use.”Read AnnouncementDesignation Grant - June 25,2025Designation Grant RMAT DesignationDrug: EG-70Announced Date: June 25, 2025Indication: for Expedited Review in High-Risk, Non-Muscle Invasive Bladder CancerAnnouncementenGene Holdings Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to detalimogene voraplasmid (also known as detalimogene, and previously EG-70), the Company's lead investigational therapy for the treatment of high-risk, Bacillus Calmette-Guérin (BCG)-unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS).AI SummaryenGene Holdings Inc. announced that the FDA has granted Regenerative Medicine Advanced Therapy (RMAT) designation to its lead investigational therapy, detalimogene voraplasmid. This designation is a key milestone for the company as it highlights the potential of the therapy to address a serious unmet need in patients with high-risk, Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS). The RMAT status is part of an FDA program designed to speed up the development and review process for treatments that can impact life-threatening conditions. With this designation, enGene will have early and frequent interactions with the FDA, along with potential benefits like a rolling review and priority review. This progress brings hope for a first-in-class, gene-based immunotherapy that could provide a new treatment option for bladder cancer patients facing limited alternatives.Read Announcement enGene FDA Events - Frequently Asked Questions Has enGene received FDA approval? As of now, enGene (ENGN) has not received any FDA approvals for its therapy in the last two years. What drugs has enGene submitted to the FDA? In the past two years, enGene (ENGN) has reported FDA regulatory activity for EG-70. What is the most recent FDA event for enGene? The most recent FDA-related event for enGene occurred on December 2, 2025, involving EG-70. The update was categorized as "Provided Update," with the company reporting: "enGene Holdings Inc. announced that the U.S. Food and Drug Administration (FDA) has selected detalimogene voraplasmid (also known as detalimogene and previously EG-70) to participate in the Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) Program.Detalimogene is a novel, investigational, non-viral gene therapy for patients with high-risk, non-muscle invasive bladder cancer (NMIBC)." What conditions do enGene's current drugs treat? Currently, enGene has one therapy (EG-70) targeting the following condition: for Expedited Review in High-Risk, Non-Muscle Invasive Bladder Cancer. More FDA Event Resources from MarketBeat FDA Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events Adagio Medical FDA EventsBioCardia FDA EventsCognition Therapeutics FDA EventsCorbus Pharmaceuticals FDA EventsPrecision BioSciences FDA EventsHUTCHMED FDA EventsEli Lilly and Company FDA EventsTeleflex FDA EventsBioMarin Pharmaceutical FDA EventsDiaMedica Therapeutics FDA EventsDyne Therapeutics FDA EventsGuardant Health FDA EventsLigand Pharmaceuticals FDA EventsMadrigal Pharmaceuticals FDA EventsMetaVia FDA Events FDA Event Stage Terminology & Abbreviation Guide NDA: New Drug Application ANDA: Abbreviated New Drug Application sNDA: Supplemental New Drug Application BLA: Biologics License Application sBLA: Supplemental Biologics License Application FDA Approved: Approved by the FDA EMA: European Medicines Agency CE Mark: European Union Certification NMPA: China National Medical Products Administration MHLW: Japanese Ministry of Health FDA Meeting: Consultation with FDA Pre-IND: Pre-Investigational New Drug Meeting Breakthrough Therapy: Special FDA designation for promising therapies Fast Track: Accelerated FDA approval pathway Orphan Drug: Designation for rare disease treatments RPD: Rare Pediatric Disease Designation RMAT: Regenerative Medicine Advanced Therapy DSMB Review: Data Safety Monitoring Board Review IDMC Review: Independent Data Monitoring Committee MAA: MHRA Marketing Authorization Application RTF: Refusal to File (Rejected Application) 510(k): FDA Clearance for Medical Devices Rolling Submission: Staggered regulatory review process Related Companies ADC Therapeutics FDA Events Enanta Pharmaceuticals FDA Events Fulcrum Therapeutics FDA Events Replimune Group FDA Events Century Therapeutics FDA Events Eupraxia Pharmaceuticals FDA Events Lyell Immunopharma FDA Events Monopar Therapeutics FDA Events Benitec Biopharma FDA Events Cellectis FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare and Medical Stocks FDA progress for NASDAQ:ENGN last updated on 12/2/2025 by MarketBeat.com Staff. 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Provided Update - December 2,2025Provided Update Drug: EG-70Announced Date: December 2, 2025Indication: for Expedited Review in High-Risk, Non-Muscle Invasive Bladder CancerAnnouncementenGene Holdings Inc. announced that the U.S. Food and Drug Administration (FDA) has selected detalimogene voraplasmid (also known as detalimogene and previously EG-70) to participate in the Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) Program.Detalimogene is a novel, investigational, non-viral gene therapy for patients with high-risk, non-muscle invasive bladder cancer (NMIBC).AI SummaryenGene Holdings announced that the U.S. Food and Drug Administration selected its investigational non‑viral gene therapy, detalimogene voraplasmid (detalimogene), to join the CMC Development and Readiness Pilot (CDRP) Program. Detalimogene is being developed as an intravesical treatment for patients with high‑risk non‑muscle invasive bladder cancer (NMIBC). The CDRP Program supports chemistry, manufacturing, and controls (CMC) development for products with compressed clinical timelines and aims to help patients gain earlier access to promising therapies. enGene is one of nine companies chosen for the program each year. Because detalimogene has already been manufactured at commercial scale, participation in CDRP will provide additional, structured FDA CMC interactions to help ensure manufacturing readiness ahead of a potential Biologics License Application (BLA) submission in the second half of 2026. enGene says the CDRP engagement should strengthen CMC planning and align manufacturing with regulatory expectations as clinical development proceeds toward possible approval. Read Announcement
Preliminary Data - November 11,2025Preliminary Data Phase 2Drug: EG-70Announced Date: November 11, 2025Indication: for Expedited Review in High-Risk, Non-Muscle Invasive Bladder CancerAnnouncementenGene Holdings Inc. 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 (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) patients with carcinoma in situ (CIS) with or without concomitant papillary disease.AI SummaryenGene reported additional preliminary data from the pivotal cohort of its Phase 2 LEGEND trial of detalimogene voraplasmid in high‑risk, BCG‑unresponsive non‑muscle invasive bladder cancer with carcinoma in situ. The pivotal cohort completed enrollment at 125 patients, exceeding the target. An analysis of patients treated under an amended protocol (62 patients with 3‑month data; 37 with 6‑month data) showed a 63% complete response (CR) rate at any time, 56% CR at 3 months, and 62% CR at 6 months (including four patients who converted to CR after reinduction). All five patients assessed at 9 months had a CR. Safety among 125 patients was favorable: 42% experienced a treatment‑related adverse event, mostly Grade 1–2; three patients had Grade 3 events. Dose interruptions occurred in 1.6% and discontinuations in 0.8%. Common side effects included fatigue, dysuria, bladder spasm, urgency and pollakiuria. Other LEGEND cohorts continue to enroll, and enGene plans to use these results to support a planned Biologics License Application in the second half of 2026.Read Announcement
Enrollment Update - September 3,2025Enrollment Update Phase 2Drug: EG-70Announced Date: September 3, 2025Indication: for Expedited Review in High-Risk, Non-Muscle Invasive Bladder CancerAnnouncementenGene Holdings Inc. announced it has achieved its target enrollment milestone of 100 patients for the pivotal cohort of its ongoing, open-label, multi-cohort Phase 2 LEGEND trial of detalimogene voraplasmid ("detalimogene" and previously EG-70) in patients with high-risk, non-muscle invasive bladder cancer (NMIBC).AI SummaryenGene Holdings Inc. announced it has enrolled 100 patients in the pivotal cohort of its Phase 2 LEGEND trial studying detalimogene voraplasmid in high-risk, non-muscle invasive bladder cancer (NMIBC) patients with carcinoma in situ (CIS), with or without papillary disease. The open-label, multi-cohort study remains open to screening and may overenroll beyond the initial target. The company expects to share data from LEGEND’s pivotal cohort in the fourth quarter of 2025 and plans to submit a Biologics License Application in the second half of 2026. Overenrollment could lead to a slight shift in that timeline, offering more robust safety and efficacy insights. “Reaching our enrollment goal for detalimogene in LEGEND’s pivotal cohort marks a key milestone,” said Ron Cooper, CEO of enGene. “It brings us closer to delivering the first non-viral gene therapy option that balances strong anti-tumor activity with safety and ease of use.”Read Announcement
Designation Grant - June 25,2025Designation Grant RMAT DesignationDrug: EG-70Announced Date: June 25, 2025Indication: for Expedited Review in High-Risk, Non-Muscle Invasive Bladder CancerAnnouncementenGene Holdings Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to detalimogene voraplasmid (also known as detalimogene, and previously EG-70), the Company's lead investigational therapy for the treatment of high-risk, Bacillus Calmette-Guérin (BCG)-unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS).AI SummaryenGene Holdings Inc. announced that the FDA has granted Regenerative Medicine Advanced Therapy (RMAT) designation to its lead investigational therapy, detalimogene voraplasmid. This designation is a key milestone for the company as it highlights the potential of the therapy to address a serious unmet need in patients with high-risk, Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS). The RMAT status is part of an FDA program designed to speed up the development and review process for treatments that can impact life-threatening conditions. With this designation, enGene will have early and frequent interactions with the FDA, along with potential benefits like a rolling review and priority review. This progress brings hope for a first-in-class, gene-based immunotherapy that could provide a new treatment option for bladder cancer patients facing limited alternatives.Read Announcement
