enGene Therapeutics Inc. - Common Stock (ENGN)

enGene Therapeutics Inc. (Nasdaq: ENGN or “enGene” or the “Company”), a clinical-stage, non-viral genetic medicines company, today reported additional interim results from the pivotal cohort of its ongoing, Phase 2 LEGEND trial of detalimogene voraplasmid (also known as detalimogene) 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, which enrolled 125 patients. These data, as of April 21, 2026, demonstrated that patients treated with detalimogene achieved a 54% complete response (CR) at any time and a 43% CR rate at six months. The progression rate to muscle-invasive or advanced disease was low, at 3.2%. Detalimogene was generally well tolerated with 55% of patients having experienced a treatment-related adverse event, mostly mild (Grade 1 and 2).

enGene Therapeutics Inc. (formerly, enGene Holdings Inc.) (Nasdaq: ENGN, “enGene” or the “Company”), a clinical-stage, non-viral genetic medicines company, is pleased to announce that it will change its corporate name to “enGene Therapeutics Inc.” effective April 8, 2026. The Company elected to change its corporate name to reflect the near-term transition to a commercial organization with the potential approval of detalimogene voraplasmid in 2027. enGene's ongoing LEGEND trial is investigating detalimogene across several cohorts of high-risk non-muscle invasive bladder cancer (NMIBC), including a pivotal cohort in BCG-unresponsive NMIBC with carcinoma in situ (CIS).

enGene Holdings Inc. (Nasdaq: ENGN, “enGene” or the “Company”), a clinical-stage, non-viral genetic medicines company, today announced its financial results for the first quarter ended January 31, 2026, and provided a business update.

enGene Holdings Inc. (Nasdaq: ENGN or “enGene”), a clinical-stage, non-viral genetic medicines company, today announced that management will participate in the following investor conferences:

enGene Holdings Inc. (Nasdaq: ENGN or “enGene”), 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 Emerging Outlook: Biotech Summit 2026 on Wednesday, February 11, 2026, at 2:30 p.m. ET.

enGene Holdings Inc. (Nasdaq: ENGN, “enGene” or the “Company”), a clinical-stage, non-viral genetic medicines company, today announced that it has entered into an amendment to an amended and restated loan and security agreement (as amended, the “Loan Agreement”) with two of its subsidiaries and Hercules Capital, Inc. (NYSE: HTGC) (“Hercules”), as agent, for up to US$125 million. Access to the additional non-dilutive capital strengthens enGene’s balance sheet in preparation for its planned Biologics License Application (“BLA”) to the U.S. Food and Drug Administration (“FDA”) for detalimogene voraplasmid as a treatment for high-risk, Bacillus Calmette-Guérin (“BCG”)-unresponsive non-muscle invasive bladder cancer (“NMIBC”) with carcinoma in situ (“CIS”) in the second half of 2026, and the potential commercial launch of detalimogene should it receive FDA approval.

enGene Holdings Inc. (Nasdaq: ENGN, “enGene” or the “Company”), a clinical-stage, non-viral genetic medicines company, today announced its financial results for the full year ended October 31, 2025, and provided a business update.

enGene Holdings Inc. (Nasdaq: ENGN or “enGene” or the “Company”), a clinical-stage, non-viral genetic medicines company, today 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).

enGene Holdings Inc. (Nasdaq: ENGN or “enGene”), 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 Healthcare Conference on Tuesday, December 2, 2025, at 12:10 p.m. ET.

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 sold in the offering will be offered by enGene. In addition, enGene has granted to the underwriters a 30-day option to purchase up to 2,294,117 additional common shares at the public offering price, less underwriting discounts and commissions. The offering is expected to close on or about November 14, 2025, subject to the satisfaction of customary closing conditions.

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.

enGene Holdings Inc. (Nasdaq: ENGN or “enGene” or the “Company”), 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 (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) patients with carcinoma in situ (CIS) with or without concomitant papillary disease. Detalimogene’s preliminary data to date and differentiated profile continue to support the Company’s planned Biologics License Application (BLA) submission in the second half of 2026.

enGene Holdings Inc. (Nasdaq: ENGN or “enGene” or the “Company”), 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.

enGene Holdings Inc. (Nasdaq: ENGN or “enGene”), a clinical-stage, non-viral genetic medicines company, today announced that management will participate in the following investor conferences in November:

enGene Holdings Inc. (“enGene” or the “Company”) (Nasdaq: ENGN), a clinical-stage, non-viral genetic medicines company, today announced that BioSpace has named the company to its 2026 Best Places to Work. enGene is among 50 U.S. operating employers recognized as one of the most desirable workplaces in the life sciences industry.

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 closing price of the Company's common shares on September 30, 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 commencement date and the remainder vesting in equal amounts monthly for three years thereafter, subject to the employee’s continued service as an employee of, or other service provider to, the Company through the applicable vesting dates.

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.

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.

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 detalimogene in patients with high-risk NMIBC with carcinoma in-situ (CIS) with or without concomitant papillary disease. Patients in the screening process remain eligible for potential enrollment in the trial. The Company expects to overenroll in its pivotal cohort resulting in an adjustment in guidance for a BLA submission to 2H 2026.

enGene Holdings Inc. (Nasdaq: ENGN or “enGene”), a clinical-stage, non-viral gene therapy company, today announced that management will participate in the following investor conferences in September:

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 employment commencement date and the remainder vesting in equal amounts monthly for three years thereafter, subject to the employee’s continued service as an employee of, or other service provider to, the Company through the applicable vesting dates.

enGene Holdings Inc. (Nasdaq: ENGN or “enGene” or the “Company”), 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 transition toward planned commercialization of its lead investigational therapy, detalimogene. In connection with the appointment of the new directors, Jasper Bos, Ph.D., stepped down from the Board.

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 (NMIBC) with carcinoma in situ (CIS).

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 price of the Company's common shares on June 16, 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 commencement date and the remainder vesting in equal amounts monthly for three years thereafter, subject to the employee’s continued service as an employee of, or other service provider to, the Company through the applicable vesting dates.

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.