ENGN Jun 15, 2026ENGNGeneral
▲ +9.3%on this news
enGene Reports Second Quarter 2026 Financial Results and Provides Business Update
enGene has reported its financial results for the second quarter of 2026 and provided a business update. However, the article lacks specific details regarding the financial performance or business developments. The information presented is minimal and does not elaborate on any significant changes or outcomes.
Read more →
ENGN Jun 15, 2026ENGNFDA Updates
▲ +9.3%on this newsshared move
enGene Therapeutics Inc. Condensed Consolidated Statements of Operations Information (unaudited) (Amounts in thousands of USD, except share and per share data) Three Months Ended April 30, Six Months Ended
enGene Therapeutics Inc. reported its second quarter 2026 financial results, announcing positive interim data from its LEGEND pivotal cohort studying detalimogene for non-muscle invasive bladder cancer. With a focus on initiating a Biologics License Application (BLA) filing in the second half of 2026, the company has begun enrolling patients in a new surfactant cohort. However, enGene has downsized its workforce by approximately 50% to conserve cash, amid ongoing financial losses. The company remains optimistic about potential regulatory approval in the upcoming year.
Read more →
ENGN May 7, 2026ENGNPhases
▼ -80.6%on this news
enGene Announces Updated Interim Results From LEGEND Pivotal Cohort
enGene Therapeutics has reported updated interim results from the Phase 2 LEGEND trial of detalimogene voraplasmid for high-risk NMIBC patients. The trial showed a 54% complete response rate at any time and a low progression rate to muscle-invasive disease. While the treatment was generally well tolerated, durability outcomes were not as expected, prompting further evaluation.
Read more →
ENGN Apr 7, 2026ENGNGeneral
enGene Announces Name Change to enGene Therapeutics Inc.
enGene has announced a name change to enGene Therapeutics Inc. This rebranding reflects the company's focus on therapeutic development. The announcement is part of a broader strategy to enhance its market presence and align its identity with its mission.
Read more →
ENGN Mar 9, 2026ENGNFDA Updates
▼ -18.8%on this news
enGene Reports First Quarter 2026 Financial Results and Provides Business Update
enGene Holdings Inc. reported its first quarter 2026 financial results, highlighting a strong cash position and plans for a Biologics License Application (BLA) submission for detalimogene in the second half of 2026. The company anticipates presenting data from its LEGEND pivotal cohort at a spring medical conference. Despite an increase in net loss, enGene remains optimistic about the potential of detalimogene for treating high-risk bladder cancer.
Read more →
ENGN Feb 20, 2026ENGNConferences/Events
enGene to Participate in Upcoming Investor Conferences
enGene Holdings Inc. announced its participation in several upcoming investor conferences, including the Oppenheimer 36th Annual Healthcare Life Sciences Conference and the Barclays 28th Annual Global Healthcare Conference. The company aims to showcase its advancements in genetic medicines, particularly its lead program for Non-Muscle Invasive Bladder Cancer. Live webcasts of the events will be available on their website.
Read more →
ENGN Feb 20, 2026ENGNConferences/Events
enGene to Participate in Upcoming Investor Conferences - February 20, 2026
enGene Holdings Inc. announced its participation in several upcoming investor conferences, including the Oppenheimer 36th Annual Healthcare Life Sciences Conference and the Barclays 28th Annual Global Healthcare Conference. The company is focused on developing genetic medicines, particularly its lead program for Non-Muscle Invasive Bladder Cancer. These events will provide opportunities for management to engage with investors and discuss their ongoing clinical trials.
Read more →
ENGN Feb 5, 2026ENGNConferences/Events
▼ -7.6%on this news
enGene to Participate in the Guggenheim Emerging Outlook: Biotech Summit 2026
enGene Holdings Inc. announced that CEO Ron Cooper will participate in a fireside chat at the Guggenheim Emerging Outlook: Biotech Summit 2026. The event is scheduled for February 11, 2026, and will be accessible via a live webcast. enGene is advancing genetic medicines, particularly its lead program for Non-Muscle Invasive Bladder Cancer.
Read more →
ENGN Jan 21, 2026ENGNFDA Updates
enGene Announces Expanded $125 Million Debt Facility with Hercules Capital, Inc.
enGene Holdings Inc. has announced an expanded debt facility of up to $125 million with Hercules Capital. The funding will support the development and commercialization of detalimogene voraplasmid for treating high-risk, BCG-unresponsive non-muscle invasive bladder cancer. The company plans to file a Biologics License Application with the FDA in the second half of 2026.
Read more →
ENGN Dec 18, 2025ENGNFDA Updates
enGene Reports Full Year 2025 Financial Results and Provides Business Update Completed enrollment in LEGEND's pivotal cohort with 125 patients in high-risk, BCG-unresponsive NMIBC with carcinoma in situ Reported prelimin
enGene Holdings Inc. reported its financial results for the full year ended October 31, 2025, highlighting several significant milestones. The company completed enrollment in its pivotal LEGEND cohort with 125 patients and reported a 6-month complete response rate of 62%. enGene has also been selected for the FDA's CDRP Program, which aids in chemistry, manufacturing, and controls development. However, despite these developments, the company faced a net loss of approximately $117.3 million due to increased operating expenses.
Read more →
ENGN Dec 2, 2025ENGNFDA Updates
enGene’s Detalimogene Selected for FDA Manufacturing Pilot Program to Support Manufacturing Readiness
enGene Holdings Inc. announced that its investigational gene therapy, detalimogene voraplasmid, has been selected by the FDA for the CMC Development and Readiness Pilot Program. This program aims to enhance manufacturing readiness for therapies with compressed clinical timelines. The company also reported promising results from the LEGEND trial, showing a 62% complete response rate in patients with high-risk NMIBC.
Read more →
ENGN Nov 12, 2025ENGNGeneral
enGene Announces Pricing of $130 Million Public Offering of Common Shares and Pre-Funded Warrants BOSTON & MONTREAL
enGene Holdings Inc. has announced the pricing of its public offering, which aims to raise $130 million by offering 12,558,823 common shares at $8.50 each and pre-funded warrants at $8.4999 each. The company's public offering is set to close on or about November 14, 2025, pending customary closing conditions. The additional funds raised will further support the firm's clinical programs, particularly its lead candidate aimed at non-muscle invasive bladder cancer. Jefferies, Leerink Partners, and Wells Fargo Securities are among the firms managing the offering.
Read more →
ENGN Nov 10, 2025ENGNConferences/Events
enGene to Host Conference Call to Provide Update on Pivotal Cohort of LEGEND Trial BOSTON & MONTREAL
enGene Holdings Inc. will host a conference call on November 11, 2025, to discuss preliminary data from the pivotal cohort of its LEGEND trial. The trial focuses on its gene therapy candidate, detalimogene voraplasmid, targeted at patients with high-risk, BCG-unresponsive non-muscle invasive bladder cancer. This represents a significant step in the development of therapies addressing a high clinical need within this patient population.
Read more →
ENGN Sep 30, 2025ENGNGeneral
▲ +5.9%on this news· ran to +20% by day 3
enGene Appoints Hussein Sweiti, M.D., MSc, as Chief Medical Officer Bladder cancer development leader who helped drive recent FDA product approval in NMIBC joins to lead research and development strategy Appointment stre
enGene Holdings Inc. has appointed Dr. Hussein Sweiti as Chief Medical Officer, effective September 29, 2025. Dr. Sweiti brings extensive experience in oncology clinical research and regulatory submissions, having recently led successful FDA interactions for bladder cancer treatments at Johnson & Johnson. His appointment aims to enhance enGene's clinical development and regulatory capacity in preparation for the expected BLA submission for detalimogene, an investigational treatment for high-risk non-muscle invasive bladder cancer, anticipated in the second half of 2026.
Read more →
ENGN Sep 11, 2025ENGNPhases
enGene Reports Third Quarter 2025 Financial Results and Provides Business Update Achieved target enrollment milestone for LEGEND trial pivotal cohort in high-risk BCG unresponsive NMIBC with carcinoma in situ LEGEND's pi
enGene Holdings Inc. reported positive developments in their third quarter 2025 update, achieving enrollment targets for the LEGEND trial, which focuses on detailing the efficacy of their investigational gene therapy, detalimogene, for high-risk NMIBC patients. The FDA has granted the therapy RMAT designation, enhancing regulatory advantages for the upcoming Biologic License Application planned for 2026. However, financial results revealed a net loss increase and rising operational expenses as the company expands clinical efforts and prepares for commercialization. Key data updates from the LEGEND trial are scheduled for release in Q4 2025.
Read more →
ENGN Jul 8, 2025ENGNGeneral
enGene Announces Board and Leadership Appointments to Support Commercial Readiness Philip Astley-Sparke, William Grossman and Michael Heffernan join the Board Management promotions strengthen clinical and regulatory oper
enGene Holdings Inc. announced the addition of three new members to its Board of Directors, aiming to bolster its strategic readiness for the commercialization of its investigational therapy, detalimogene. The company also promoted individuals to key leadership positions, enhancing its clinical and regulatory operations. Detalimogene, designed for patients with high-risk, non-muscle invasive bladder cancer, has received critical FDA designations, facilitating its path forward. These changes reflect enGene's commitment to addressing significant unmet medical needs in oncology.
Read more →
ENGN Jun 12, 2025ENGNPhases
enGene Reports Second Quarter 2025 Financial Results and Provides Business Update Additional preliminary data from ongoing LEGEND study of detalimogene in pivotal cohort of BCG-unresponsive NMIBC with CIS anticipated in
enGene Holdings Inc. announced its financial results for Q2 2025, reporting a net loss of $25.8 million. The company is making progress in its LEGEND study, focusing on its investigational gene therapy, detalimogene, for high-risk non-muscle invasive bladder cancer. Enrollment is strong, and an application for a Biologics License is planned for mid-2026. The company retains a solid cash position, expected to fund operations into 2027 despite rising operational costs.
Read more →
ENGN Jun 4, 2025ENGNGeneral
▼ -8.8%on this news· ran to -20% by day 3
enGene Announces the Resignation of its Chief Medical Officer BOSTON and MONTREAL
enGene Holdings Inc. announced the resignation of Dr. Raj Pruthi as Chief Medical Officer, effective June 16, 2025. Dr. Pruthi will assist in transitioning his responsibilities before his departure. The company plans to redistribute his duties among its other experts in urology and clinical affairs. The resignation raises potential leadership stability concerns as enGene remains focused on its clinical development and ongoing trials.
Read more →
ENGN Mar 10, 2025ENGNPhases
enGene Reports First Quarter 2025 Financial Results and Provides Business Update Additional preliminary data from ongoing LEGEND study of detalimogene in BCG-unresponsive NMIBC with CIS, including pivotal cohort, anticip
enGene Holdings Inc. reported its financial results for Q1 2025, highlighting expansions in its LEGEND study for detalimogene, a treatment for BCG-unresponsive NMIBC. The company anticipates pivotal cohort enrollment completion by the end of 2025 and plans to file a Biologics License Application by mid-2026. While enGene's cash reserves are sufficient to sustain operations until 2027, it also reported increased operational losses, raising concerns about future financial stability.
Read more →
ENGN Dec 19, 2024ENGNPhases
enGene Reports Full Year 2024 Financial Results and Provides a Business Update 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 u
enGene Holdings Inc. reported its financial results for the fiscal year 2024, highlighting a robust financial position with $297.9 million in cash and cash equivalents. The company announced a 71% complete response rate in preliminary data from the pivotal LEGEND study for its investigational product, detalimogene, in BCG-unresponsive NMIBC patients. All cohorts of the study are now enrolling participants, and upcoming preliminary data is expected in the second half of 2025. However, the company also noted increased operational losses, culminating in a net loss of $55.1 million for the year.
Read more →
ENGN Oct 25, 2024ENGNGeneral
enGene Announces $60 Million Private Placement Financing BOSTON and MONTREAL
enGene Holdings Inc. has announced a private placement financing agreement to raise approximately $60 million by selling 6,758,311 common shares at $8.90 per share. The financing, supported by participation from both new and existing investors, is expected to close on October 29, 2024. The funds will be used to further develop enGene's key product, detalimogene voraplasmid, as well as support pre-commercial activities and general operational needs. With these funds, enGene projects it will have sufficient resources to maintain its current operating plan through 2027.
Read more →
ENGN Oct 21, 2024ENGNGeneral
▲ +9%on this news
recent Quarterly Report on Form 10-Q for the fiscal quarter ended
enGene Holdings Inc. announced the appointments of Joan Connolly as Chief Technology Officer and Anthony Cheung, Ph.D., as Chief Scientific Officer. Connolly's extensive experience in regulatory filings and product commercialization will aid enGene’s pivotal study of detalimogene voraplasmid for high-risk NMIBC patients. The company is anticipating to file its Biologics License Application in mid-2026. Connolly expressed enthusiasm for joining enGene at a critical time, especially with the promising data emerging from the ongoing LEGEND study.
Read more →
ENGN Sep 26, 2024ENGNPhases
▼ -12%on this news
Detalimogene Demonstrates 71% Complete Response Rate at Any Time in Preliminary Analysis of LEGEND Pivotal Cohort Data from pivotal cohort demonstrate compelling clinical activity, consistent with Phase 1 results Favorab
enGene Holdings Inc. has announced preliminary data from a pivotal study of their investigational product, detalimogene voraplasmid, in patients with high-risk non-muscle invasive bladder cancer. The data reveals a 71% complete response rate at any time point, corroborating initial Phase 1 results. The therapy also demonstrated a favorable safety profile, with no treatment-related discontinuations. Future plans include refinements to the LEGEND trial protocol to enhance clinical benefits, and further enrollment in additional study cohorts is set to begin later this year.
Read more →
ENGN Sep 10, 2024ENGNGeneral
enGene Reports Third Quarter 2024 Financial Results and Provides a Business Update Company remains on track to report preliminary LEGEND data in September 2024 Cash and cash equivalents of $257.7 million provide runway i
enGene Holdings Inc. reported its financial results for the third quarter of 2024, indicating a significant increase in operating expenses and a net loss of $14.1 million. The company remains focused on its lead product, detalimogene voraplasmid, which targets high-risk, BCG-unresponsive non-muscle invasive bladder cancer. With $257.7 million in cash, enGene expects to maintain operations until 2027, while eagerly anticipating preliminary data from its pivotal LEGEND study scheduled for later this month. Key leadership changes were also highlighted to strengthen the company’s strategic position in the biotech sector.
Read more →
ENGN Sep 5, 2024ENGNGeneral
Non-Viral Genetic Medicine Corporate Presentation September 2024 Cautionary Statement Regarding Forward-Looking Statements This Presentation contains certain forward-looking statements within the meaning of the federal s
EnGene has issued a corporate presentation detailing its Non-Viral Genetic Medicine initiatives, particularly focusing on its investigational drug, detalimogene voraplasmid, which targets non-muscle invasive bladder cancer (NMIBC). The company emphasizes potential market opportunities exceeding $20 billion for NMIBC therapies, leveraging internal estimates and market data. However, the presentation includes cautionary notes about the developmental status and the risks associated with forward-looking statements, particularly regarding the efficacy and safety yet to be demonstrated in future clinical trials.
Read more →
ENGN Jul 24, 2024ENGNGeneral
enGene Announces Appointment of Ron Cooper as Chief Executive Officer Ron Cooper succeeds Jason Hanson as Chief Executive Officer and Director Company also announces Dr. Raj Pruthi s promotion to Chief Medical Officer BO
enGene Holdings Inc. has appointed Ron Cooper as the new Chief Executive Officer, succeeding Jason Hanson, who will remain as a strategic advisor. Cooper, known for his leadership in developing transformative therapeutics, aims to advance the company's lead product, EG-70, for high-risk Non-Muscle Invasive Bladder Cancer. The company also announced the promotion of Dr. Raj Pruthi to Chief Medical Officer. This transition is part of enGene's ongoing strategy to capitalize on its innovative genetic medicine platform.
Read more →
ENGN Jun 14, 2024ENGNPhases
▼ -10%on this news
enGene Reports Second Quarter 2024 Financial Results and Provides a Business Update Company announces plans for initial indication expansion for EG-70 into high-risk papillary only NMIBC BOSTON and MONTREAL
enGene Holdings Inc. reported its financial results for Q2 2024 and provided an update on its lead product, EG-70, which is in a pivotal study for high-risk NMIBC. The company announced plans to expand the LEGEND study, focusing on patients with high-risk, BCG-unresponsive papillary-only NMIBC. Despite having a strong cash position, enGene faced increased operating expenses and significant net losses during the quarter. Additionally, enrollment for one arm of the study has been paused to allow for modifications.
Read more →
ENGN Mar 11, 2024ENGNPhases
enGene Reports First Quarter 2024 Financial Results and Recent Corporate Progress Pivotal phase 2 LEGEND study of EG-70 in BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) remains on track with interim data an
enGene Holdings Inc. has reported its financial results for the first quarter of 2024, highlighting key developments in its genetic medicine pipeline. The Company raised $200 million in a private placement, securing funding until 2027, while the phase 2 LEGEND study of EG-70 for BCG-unresponsive bladder cancer remains on track. However, the Company experienced a net loss that increased compared to the previous year, and a leadership transition is underway as CEO Jason Hanson plans to resign. The Company expects interim data from ongoing studies in mid-2024.
Read more →
ENGN Feb 14, 2024ENGNGeneral
▲ +116.5%on this news
enGene Announces Oversubscribed $200 Million Private Placement Financing Financing included participation from new and existing investors Pro forma cash and cash equivalents expected to fund current operating plan into 2
enGene Holdings Inc. has announced an oversubscribed private placement financing, raising $200 million from new and existing investors at a premium price. This funding is earmarked for the continued development of their lead therapeutic candidate, EG-70, and is expected to fund operations into 2027. The transaction is anticipated to close on February 16, 2024, subject to standard conditions. Notably, various prominent investment firms participated in this financing round.
Read more →
ENGN Jan 29, 2024ENGNPhases
enGene Reports Full Year 2023 Financial Results and Recent Operational Progress Achieved primary and secondary endpoints in Phase 1 portion of LEGEND study in non-muscle invasive bladder cancer (NIMBC); pivotal portion u
enGene Holdings Inc. reported its full-year 2023 financial results, highlighting significant achievements in its clinical study for EG-70, a treatment for non-muscle invasive bladder cancer. The company successfully met endpoints in the Phase 1 portion of the LEGEND study with promising safety data and aims to present interim results in mid-2024. Additionally, enGene strengthened its financial standing through a reverse merger and secured $109 million in financing, extending its cash runway into Q2 2025. Despite a substantial increase in net loss, the company remains optimistic about the future of its gene therapy programs.
Read more →
ENGN Dec 19, 2023ENGNGeneral
▲ +6.1%on this news
enGene Appoints Lota S. Zoth, CPA, as Member of the Board of Directors Boston, Mass. and Montreal, Canada
enGene Holdings Inc. has appointed Lota S. Zoth, CPA, as a member of its Board of Directors and Audit Committee Chair. This decision is viewed as a significant milestone for the company as it seeks to advance its lead program in genetic medicines for treating non-muscle invasive bladder cancer. Zoth's extensive background in finance and operational leadership is anticipated to enhance the board's effectiveness and support enGene's mission to improve patient outcomes. The company's lead treatment, EG-70, is currently undergoing a pivotal Phase 2 clinical study.
Read more →
ENGN Nov 29, 2023ENGNGeneral
▼ -11.1%on this news· ran to +37% by day 3
enGene Appoints Ryan Daws as Chief Financial Officer Boston, Mass. and Montreal, Canada
enGene Holdings Inc. has appointed Ryan Daws as Chief Financial Officer and Head of Business Development, a move aimed at supporting the company's growth as it transitions to a public entity. Daws brings nearly 25 years of experience in life sciences and investment banking. This appointment coincides with enGene's ongoing pivotal clinical study for its lead program, EG-70, in treating BCG-unresponsive non-muscle invasive bladder cancer. The company aims to advance genetic medicines to wider patient populations and anticipates interim data from its trial in mid-2024.
Read more →
ENGN Oct 31, 2023ENGNGeneral
UNAUDITED PRO FORMA CONDENSED COMBINED FINANCIAL INFORMATION The following unaudited pro forma condensed combined balance sheet as of
The article presents unaudited pro forma condensed combined financial information for enGene, New enGene, and FEAC following their recent business combination. It includes the financial position as of July 31, 2023, and operational results for the nine months ending on the same date, as well as for the fiscal year ended October 31, 2022. The figures suggest that after redemptions, a substantial portion of cash remains in trust accounts, indicating some financial stability. Additionally, this pro forma financial data is meant for illustrative purposes only and does not imply future performance accuracy for the Combined Company.
Read more →