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

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

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

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

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

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

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

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

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

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

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

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

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

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

Morgan Stanley initiated coverage of enGene Holdings with a rating of Overweight and set a new price target of $40.00

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

10-Q - enGene Holdings Inc. (0001980845) (Filer)

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

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

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

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

DEF 14A - enGene Holdings Inc. (0001980845) (Filer)

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

10-Q - enGene Holdings Inc. (0001980845) (Filer)

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

enGene 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 grant date of July 31, 2025. The inducement awards consist of non-qualified stock options to purchase an aggregate 93,200 of the Company's common shares. The options each have an exercise price of $3.79 per share, which is equal to the closing price of the Company's common shares on July 31, 2025, the date of grant. Each stock option has a 10-year term and will vest over four years, with 25% of the underlying shares vesting on the one-year anniversary of the employee's employm

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

Regenerative 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. (NASDAQ:ENGN, or "enGene" or the "Company")), a clinical-stage, non-viral gene-based immunotherapy company, today 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 (N

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 Amy Pott, Chief Global Commercialization Officer, with a grant date of June 16, 2025. The inducement award for Ms. Pott consists of a non-qualified stock option to purchase an aggregate 400,000 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 53,450 of the Company's common shares. The options each have an exercise price of $3.31 per share, which is equal to the closing pri

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

enGene 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 Chief Medical Officer will take effect on June 16, 2025. He will be supporting the organization to ensure an orderly transition of his responsibilities before he departs. The Company intends to reallocate Dr. Pruthi's responsibilities to the Company's other urology and clinical experts. The Company thanks Dr. Pruthi for his dedication and service and wishes him the best in his future endeavors. About enGene enGene is a clinical-stage biotechnology company mainstreaming g

enGene 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 City on Wednesday, June 4, 2025, at 11:05 a.m. ET. A live webcast of the presentation 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 clinical-stage biotechnology company mainstreaming genetic medicines through the delivery of therapeutics to mucosal tissues and other organs, with the goal of creating new ways to address diseases with high clinical needs. enGene's lea

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, non-viral genetic medicines company, today announced that management will present at upcoming investor conferences in May 2025. Details of the conferences are below: Conference: 2025 Bloom Burton & Co. Healthcare Investor Conference Date: Monday, May 5, 2025 Time: 2:30 p.m. ET Format: Corporate Presentation Conference: The Citizens Life Sciences Conference Date: Wednesday, May 7, 2025 Time: 11:30 a.m. ET Format: Fireside Chat A live webcast of these presentations 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 clinical-stage biotec

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 seven newly-hired employees, with a grant date of April 2, 2025. The inducement awards consist of a non-qualified stock options to purchase an aggregate 144,650 of the Company's common shares. The options each have an exercise price of $4.44 per share, which is equal to the closing price of the Company's common shares on April 2, 2025, the date of grant. Each stock option has a 10-year term and will vest over four years, with 25% of the underlying shares vesting on the one-year anniversary of the employee's employment

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

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. 

Experienced biotech executive brings public company expertise in legal, corporate governance, and compliance to support enGene during late-stage clinical development and anticipated future commercial launch of its lead program EG-70 BOSTON and MONTREAL, Jan. 30, 2024 /PRNewswire/ - enGene Holdings Inc. ("enGene," (Nasdaq: ENGN), a clinical-stage genetic medicines company whose lead program is in a pivotal study for BCG-unresponsive non-muscle invasive bladder cancer (NMIBC), today announced the appointment of Lee Giguere as Chief Legal Officer and Corporate Secretary. "I am de

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