4 - enGene Holdings Inc. (0001980845) (Issuer)

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SCHEDULE 13G - enGene Holdings Inc. (0001980845) (Subject)

SCHEDULE 13G - enGene Holdings Inc. (0001980845) (Subject)

8-K - enGene Holdings Inc. (0001980845) (Filer)

SCHEDULE 13G/A - enGene Holdings Inc. (0001980845) (Subject)

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8-K - enGene Holdings Inc. (0001980845) (Filer)

Raymond James upgraded enGene Holdings from Outperform to Strong Buy and set a new price target of $27.00

Piper Sandler initiated coverage of enGene Holdings with a rating of Overweight and set a new price target of $26.00

UBS downgraded enGene Holdings from Buy to Neutral and set a new price target of $7.00 from $34.00 previously

H.C. Wainwright initiated coverage of enGene Holdings with a rating of Buy and set a new price target of $25.00

Raymond James initiated coverage of enGene Holdings with a rating of Outperform and set a new price target of $23.00

JMP Securities initiated coverage of enGene Holdings with a rating of Mkt Outperform and set a new price target of $18.00

Oppenheimer initiated coverage of enGene Holdings with a rating of Outperform and set a new price target of $30.00

Wells Fargo initiated coverage of enGene Holdings with a rating of Overweight and set a new price target of $30.00

Guggenheim initiated coverage of enGene Holdings with a rating of Buy and set a new price target of $34.00

UBS initiated coverage of enGene Holdings with a rating of Buy and set a new price target of $37.00

enGene Holdings Inc. (NASDAQ:ENGN, "enGene" or the "Company")), a clinical-stage, non-viral genetic medicines company, today announced the pricing of its previously announced underwritten public offering of 12,558,823 common shares at a public offering price of $8.50 per share and pre-funded warrants to purchase 2,735,295 shares of its common shares at an offering price of $8.4999 per pre-funded warrant, in each case, before underwriting discounts and commissions. The aggregate gross proceeds to enGene from the offering, before deducting the underwriting discounts and commissions and offering expenses payable by enGene, are expected to be approximately $130 million. All securities to be sol

enGene 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 common shares to be sold in the offering will be offered by enGene. In addition, enGene intends to grant the underwriters a 30-day option to purchase up to a number of additional common shares equal to 15% of the total number of common shares sold in the proposed offering, on the same terms and conditions. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the proposed offering may be completed, or as to the actu

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

enGene 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 Healthcare Innovation Conference Date: Tuesday, November 11, 2025 Time: 12:30 p.m. ET Stifel 2025 Healthcare Conference Date: Wednesday, November 12, 2025 Time: 2:00 p.m. ET Jefferies Global Healthcare Conference in London Date: Tuesday, November 18, 2025 Time: 8:30 a.m. GMT / 3:30 a.m. ET A live webcast of these events can be accessed under the "Investors" section of the enGene website at www.engene.com and will be archived there for 90 days. About enGene enGene is a clinica

Equity Insider News Commentary Issued on behalf of GT Biopharma, Inc. VANCOUVER, BC, Oct. 7, 2025 /PRNewswire/ -- Equity Insider News Commentary – Major pharmaceutical companies presenting at the European Society for Medical Oncology Congress October 17-21[1] are unveiling pivotal survival data[2] and late-breaking lung cancer[3] results that demonstrate how diverse mechanisms are succeeding where traditional approaches stalled, while regulatory agencies issued multiple September approvals spanning gene therapies, bispecifics, and novel delivery systems[4]. The momentum reflects a fundamental shift as researchers discovered how cancer hijacks immune pathways to evade attack, spurring develop

enGene 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 Hussein Sweiti, M.D., MSc, Chief Medical Officer, with a grant date of September 30, 2025. The inducement award for Dr. Sweiti consists of a non-qualified stock option to purchase an aggregate 600,000 of the Company's common shares. The inducement awards for the other three newly-hired employees consist of non-qualified stock options to purchase an aggregate 57,950 of the Company's common shares. The options each have an exercise price of $6.83 per share, which is equal to the clos

Bladder 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 capabilities ahead of planned 2H 2026 BLA submission for detalimogene enGene Holdings Inc. (NASDAQ:ENGN, "enGene" or the "Company")), a clinical-stage, non-viral genetic medicine company, today announced that Hussein Sweiti, M.D., MSc, was appointed Chief Medical Officer, effective September 29, 2025. Dr. Sweiti is a surgical oncologist and physician-scientist with more than 15 years of experience spanning clinical practice, oncology clinical research, global drug development, regula

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'

Target 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 planned for 2H 2026 enGene Holdings Inc. (NASDAQ:ENGN, "enGene" or the "Company")), a clinical-stage, non-viral gene therapy company, today 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). LEGEND's pivotal Cohort 1 is studying detalim

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.

Bladder 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 capabilities ahead of planned 2H 2026 BLA submission for detalimogene enGene Holdings Inc. (NASDAQ:ENGN, "enGene" or the "Company")), a clinical-stage, non-viral genetic medicine company, today announced that Hussein Sweiti, M.D., MSc, was appointed Chief Medical Officer, effective September 29, 2025. Dr. Sweiti is a surgical oncologist and physician-scientist with more than 15 years of experience spanning clinical practice, oncology clinical research, global drug development, regula

Philip 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 Development Officer, and Katherine Chan Executive Director, Urology Clinical Lead enGene Holdings Inc. (NASDAQ:ENGN), a clinical-stage, non-viral gene-based immunotherapy company, today announced the appointment of three new members to its Board of Directors: Philip Astley-Sparke, William Grossman, M.D., Ph.D., and Michael Heffernan, R.Ph. Their combined experience across gene therapy, oncology, clinical development, and global product launches will support enGene's strategic transit

enGene 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 Company's first dedicated executive for commercialization planning and execution, reporting to enGene's Chief Executive Officer, Ron Cooper. This appointment marks a significant milestone, as the Company expects to file a Biologics License Application (BLA) with the FDA in mid-2026 for detalimogene voraplasmid, its lead investigational agent in Bacillus Calmette-Guérin (BCG)-unresponsive, non-muscle invasive bladder cancer (NMIBC), following the completion of the pivotal co

enGene 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 pivotal study in patients with high-risk, Bacillus Calmette-Guérin (BCG)-unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (Cis), today announced the appointment of Joan Connolly as Chief Technology Officer (CTO) and member of the corporate leadership team. In addition, enGene Co-Founder and former CTO, Anthony Cheung, Ph.D., will transition to the role of Chief Scientific Officer, succeeding James Sullivan, MSc, Ph.D. Ms. Connolly's career spans

Ron Cooper succeeds Jason Hanson as Chief Executive Officer and Director Company also announces Dr. Raj Pruthi's promotion to Chief Medical Officer 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 that Ron Cooper has joined the Company as Chief Executive Officer and member of the Board of Directors, effective July 22, 2024. This transition follows a previously announced succession plan for Jason Hanson, who will remain in service to the Company as a strategi

enGene Holdings Inc. (NASDAQ:ENGN), a clinical-stage genetic medicines company whose non-viral lead program EG-70 is in a pivotal study for BCG-unresponsive non-muscle invasive bladder cancer (NMIBC), today announced the election of Paul Hastings and Wouter Joustra as new members of its Board of Directors at the Company's 2024 annual meeting of shareholders. Shareholders also reelected incumbent director Lota Zoth. Each will serve a three-year term expiring at the 2027 annual meeting of shareholders. enGene's Board is now comprised of seven members including Richard Glickman (Chairman), Gerald Brunk, Jasper Bos, and Jason Hanson. "We are pleased to welcome Paul and Wouter to our Board of

BOSTON and MONTREAL, April 9, 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 that Raj Pruthi MD MHA FACS has joined the Company as SVP, Urologic Oncology and Clinical Development, reporting to enGene's Chief Medical Officer, Dr. Richard Bryce. In this role, Dr. Pruthi's responsibilities will include supporting the clinical development of EG-70 across the urologic space, including through engagement with the urological community. He joins enGene fr

BOSTON and MONTREAL, April 9, 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 that Raj Pruthi MD MHA FACS has joined the Company as SVP, Urologic Oncology and Clinical Development, reporting to enGene's Chief Medical Officer, Dr. Richard Bryce. In this role, Dr. Pruthi's responsibilities will include supporting the clinical development of EG-70 across the urologic space, including through engagement with the urological community. He joins enGene fr

BOSTON and MONTREAL, April 9, 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 that Raj Pruthi MD MHA FACS has joined the Company as SVP, Urologic Oncology and Clinical Development, reporting to enGene's Chief Medical Officer, Dr. Richard Bryce. In this role, Dr. Pruthi's responsibilities will include supporting the clinical development of EG-70 across the urologic space, including through engagement with the urological community. He joins enGene fr

BOSTON and MONTREAL, Feb. 14, 2024 /PRNewswire/ - enGene Holdings Inc. (NASDAQ:ENGN) ("enGene" or the "Company"), a clinical-stage genetic medicines company whose non-viral lead program EG-70 is in a pivotal study for BCG-unresponsive non-muscle invasive bladder cancer (NMIBC), today announced that due to personal family and health reasons, Jason Hanson intends to resign from his role as Chief Executive Officer and a member of the Board of Directors upon the appointment of a successor CEO. The Board of Directors has initiated a search for his successor. Following the hiring of a new CEO, he will support the Company and the new CEO as a strategic advisor. 

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