Detalimogene program drives enGene (ENGN) shift to Therapeutics focus
Rhea-AI Filing Summary
enGene Therapeutics Inc., formerly enGene Holdings Inc., has changed its corporate name to enGene Therapeutics Inc., effective April 8, 2026. The amendment affects only the name; no other changes were made to the company’s articles. The company’s common shares and warrants will continue trading on Nasdaq under the symbols ENGN and ENGNW, respectively.
In a related press release, enGene explained that the new name reflects its transition toward potential commercialization of its lead gene therapy detalimogene voraplasmid. The company plans a Biologics License Application submission for detalimogene in the second half of 2026, targeting potential approval and a commercial organization in 2027.
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8-K Event Classification
Key Figures
Key Terms
Biologics License Application (BLA) regulatory
Regenerative Medicine Advanced Therapy (RMAT) regulatory
Fast Track designation regulatory
non-muscle invasive bladder cancer (NMIBC) medical
Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) regulatory
Dually Derivatized Oligochitosan (DDX) platform technical
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Item 5.03 Amendments to Articles of Incorporation or Bylaws; Change in Fiscal Year.
On April 6, 2026, enGene Therapeutics Inc., formerly known as enGene Holdings Inc. (the “Company”), filed a notice of alteration (the “Notice of Alteration”) with the Province of British Columbia Registrar of Companies to change the Company’s corporate name to enGene Therapeutics Inc., effective as of April 8, 2026 (the “Name Change”). A copy of the Notice of Alteration, Notice of Articles and Certificate of Change of Name is attached as Exhibit 3.1 hereto and is incorporated by reference herein.
In connection with the Name Change, the board of directors amended the articles of the Company (the “Articles”) to reflect the corporate name enGene Therapeutics Inc., effective as of April 8, 2026. No other changes were made to the Company’s Articles. A copy of the Company’s amended Articles reflecting the Name Change is attached as Exhibit 3.2 hereto and incorporated by reference herein.
The Company’s common shares, no par value per share, and the Company’s warrants, each exercisable for one common share at an exercise price of $11.50 per share, will continue to trade on the Nasdaq Stock Market under the ticker symbols “ENGN” and “ENGNW”, respectively.
Item 7.01 Regulation FD Disclosure.
On April 7, 2026, the Company issued a press release announcing the Name Change. A copy of the press release is being furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information in this Item 7.01, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
Exhibit No. |
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Description of Exhibits |
3.1* |
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Notice of Alteration, Notice of Articles and Certificate of Change of Name, effective as of April 8, 2026. |
3.2 |
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Articles of enGene Therapeutics Inc., as amended April 8, 2026. |
99.1 |
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Press Release of the Company, dated April 7, 2026. |
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Cover Page Interactive Data File (embedded within the Inline XBRL document) |
* Certain portions of this Exhibit marked as [***] have been redacted pursuant to Item 601(a)(6) of Regulation S-K under the Exchange Act.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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ENGENE THERAPEUTICS INC. |
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Date: |
April 9, 2026 |
By: |
/s/ Lee G. Giguere |
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Name: Lee G. Giguere |
Exhibit 99.1
enGene Announces Name Change to enGene Therapeutics Inc.
Name change reflects transition towards potential commercial organization in 2027
Planned Biologics License Application (BLA) submission for detalimogene in 2H 2026
BOSTON & MONTREAL--(BUSINESS WIRE)--April 7, 2026--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).
“We’re entering an important next phase for enGene as we prepare for potential approval of detalimogene in 2027,” said Ron Cooper, President and Chief Executive Officer, enGene. “Our new name reflects our progress — and the opportunity to bring detalimogene to patients and the practices that care for them, where more options are still needed.”
The Company’s common shares (the “Common Shares”) will continue to trade on the Nasdaq Capital Market (the “Nasdaq”) under the symbol “ENGN”, and the Company’s listed common share purchase warrants (the “Warrants”) will continue to trade on the Nasdaq under the symbol “ENGNW”.
The corporate name change does not affect the rights of security holders, and no further action is required by security holders with respect to the change. As of the effective date, the CUSIP numbers and ISINs of the Common Shares and Warrants will change. The new CUSIP number for the Common Shares is 29286X101 and the new ISIN number is CA29286X1015. The new CUSIP number for the Warrants is 29286X119 and the new ISIN number is CA29286X1197.
About Non-Muscle Invasive Bladder Cancer (NMIBC)
Non-muscle invasive bladder cancer (NMIBC) is a disease that poses a significant burden on both patients and clinics and has a massive economic impact on our healthcare system. NMIBC occurs when cancer cells grow in the tissues that line the interior of the bladder, but the cancer has not yet penetrated the muscle of the bladder wall. NMIBC can present as papillary outgrowths from the bladder wall, which are typically resected, or as carcinoma in situ (CIS), which consists of flat, multifocal lesions that cannot be resected. The two forms can also co-occur. About 75-80% of new bladder cancer diagnoses are NMIBC. Patients suffering from high-risk NMIBC who are unresponsive to the standard of care, Bacillus Calmette-Guérin
(BCG), face high rates of disease recurrence (50-70%) and are potentially subject to full removal of the bladder (cystectomy) as a curative but life-altering next step.
About Detalimogene Voraplasmid
Detalimogene is a novel, investigational, non-viral gene therapy for patients with high-risk, non-muscle invasive bladder cancer (NMIBC), including Bacillus Calmette-Guérin (BCG)-unresponsive disease. It is designed to be instilled in the bladder and elicit a powerful yet localized anti-tumor immune response.
Detalimogene was developed using the Company’s Dually Derivatized Oligochitosan® (DDX) platform, a technology designed to transform how gene therapies are accessed by patients and utilized by clinicians. Medicines developed with the DDX platform can potentially overcome the limitations of viral-based gene therapies, reduce complexities related to safe handling and cold storage, and streamline both manufacturing processes and administration paradigms.
Detalimogene has received Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations from the U.S. Food and Drug Administration (FDA) based on its potential to address the high unmet medical need for patients with BCG-unresponsive carcinoma in situ (CIS) NMIBC with or without resected papillary tumors who are unable to undergo cystectomy. The RMAT program is intended to expedite the development and review of regenerative medicine therapies for serious or life-threatening conditions, where preliminary clinical evidence suggests potential to address unmet medical needs. Similarly, Fast Track designation is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. Detalimogene has also been selected to participate in the FDA’s Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) program. The FDA created the CDRP Program to facilitate CMC development for therapies with compressed clinical development timeframes based on the anticipated clinical benefits of earlier patient access to the therapy.
About the LEGEND Trial
Detalimogene is being evaluated in the ongoing, open-label, multi-cohort, Phase 2 LEGEND trial to establish its safety and efficacy in high-risk NMIBC. LEGEND’s pivotal cohort (Cohort 1) consists of 125 patients with high-risk, BCG-unresponsive NMIBC with CIS (with or without papillary disease) and is designed to serve as the basis of the Company’s planned Biologics License Application (BLA) filing. In addition to this pivotal cohort, LEGEND includes three additional cohorts, including NMIBC patients with CIS who are naïve to treatment with BCG (Cohort 2a); NMIBC patients with CIS who have been exposed to BCG but have not received adequate BCG treatment (Cohort 2b); and BCG-unresponsive high-risk NMIBC patients with papillary-only disease (Cohort 3). The LEGEND trial is actively enrolling patients with sites participating in the USA, Canada, Europe, and the Asia-Pacific region.
About enGene
enGene Therapeutics Inc. is a clinical-stage biotechnology company mainstreaming gene therapy 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 lead program is detalimogene voraplasmid (also known as detalimogene) for patients with Non-Muscle
Invasive Bladder Cancer (NMIBC), a disease with a high clinical burden. Detalimogene is being evaluated in the ongoing multi-cohort LEGEND Phase 2 trial, which includes a pivotal cohort studying detalimogene in high-risk, Bacillus Calmette-Guérin (BCG)-unresponsive patients with carcinoma in situ (CIS) with or without concomitant papillary disease. Detalimogene was developed using enGene’s proprietary Dually Derivatized Oligochitosan (DDX) platform, which enables penetration of mucosal tissues and delivery of a wide range of sizes and types of cargo, including DNA and various forms of RNA.
To learn more, please visit enGene.com and follow us on LinkedIn, X and BlueSky.
Forward-Looking Statements
Certain statements contained in this press release may constitute “forward-looking statements” within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, and “forward-looking information” within the meaning of Canadian securities laws (collectively, “forward-looking statements”). enGene’s forward-looking statements include, but are not limited to, statements relating to the Company’s future plans, expectations and objectives. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words “anticipate”, “appear”, “approximate”, “believe”, “continue”, “could”, “estimate”, “expect”, “foresee”, “goal”, “intends”, “may”, “might”, “plan”, “possible”, “potential”, “predict”, “project”, “seek”, “should”, “would”, and similar expressions (or the negative version of such words or expressions) may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. Forward-looking statements may include, for example, statements about: the Company’s plans and expectations regarding a potential BLA submission for detalimogene and potential approval and commercial launch of detalimogene, the future development of detalimogene and the potential benefits of detalimogene. Such statements are subject to numerous important factors, risks and uncertainties, many of which are beyond enGene's control, that may cause actual events or results to differ materially from enGene's current expectations. For example, there can be no guarantee that detalimogene will successfully complete necessary clinical development phases, including achieving positive results in the pivotal cohort of the LEGEND study, or that those results or any feedback from regulatory authorities will ultimately lead to BLA submission for, and the approval of, detalimogene.
Management's expectations and, therefore, any forward-looking statements in this press release could also be affected by risks, uncertainties and assumptions relating to a number of other factors, which could cause the Company’s actual results, performance or achievements to differ materially from those expressed or implied by the forward-looking statements, including, without limitation, the failure to receive required approvals, and other risks and uncertainties detailed in filings with Canadian securities regulators on SEDAR+ and with the U.S. Securities and Exchange Commission (“SEC”) on EDGAR, including those described in the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the fiscal year ended October 31, 2025 (copies of which may be obtained at www.sedarplus.ca or www.sec.gov).
You should not place undue reliance on any forward-looking statements, which speak only as of the date on which they are made. enGene anticipates that subsequent events and developments will cause enGene’s assessments to change. While enGene may elect to update these forward-looking statements at some point in the future, enGene specifically disclaims any obligation to do so, unless required by applicable law. Nothing in this press release should
be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved.
Media Contact:
J.C. Molina
jmolina@engene.com
Investor Contact:
Lauren Stival Hopfer
lhopfer@engene.com