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enGene Holdings Inc. Stock Price, News & Analysis

ENGN Nasdaq

Welcome to our dedicated page for enGene Holdings news (Ticker: ENGN), a resource for investors and traders seeking the latest updates and insights on enGene Holdings stock.

enGene Holdings Inc. (ENGN) is a clinical-stage biotechnology pioneer developing non-viral gene therapies through its proprietary DDX delivery platform. This page serves as the definitive source for verified company news and press releases, providing stakeholders with timely updates on therapeutic advancements and corporate developments.

Investors and researchers will find curated information spanning clinical trial progress, regulatory milestones, and strategic partnerships. Our collection focuses on critical updates including:

- Phase developments for lead candidate EG-70 in bladder cancer treatment
- Innovations in mucosal-targeted gene delivery systems
- Collaborations advancing genetic medicine applications
- Peer-reviewed research publications and conference presentations

Bookmark this page for direct access to primary source materials from enGene, ensuring you stay informed about advancements in localized gene therapy solutions addressing high-need oncological conditions. All content is vetted for accuracy and updated systematically to reflect the company's progress in transforming genetic medicine.

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enGene Holdings (Nasdaq: ENGN) reported Q1 2025 financial results and provided updates on its LEGEND study of detalimogene in BCG-unresponsive NMIBC. The company expanded trial sites into Europe and Asia, with all four LEGEND cohorts now open for enrollment. The study includes a new maintenance dosing protocol allowing complete responders to continue treatment for up to three years.

Financial highlights:

  • Cash position: $272.8 million, providing runway into 2027
  • Q1 2025 operating expenses: $26.6 million (vs $10.8 million in Q1 2024)
  • Net loss: $24.6 million ($0.48 per share)
  • R&D expenses increased by $14.3 million due to LEGEND study costs

The company remains on track for its planned Biologics License Application (BLA) filing in mid-2026, with additional preliminary data from the LEGEND study expected in H2 2025.

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enGene Holdings (Nasdaq: ENGN), a clinical-stage, non-viral genetic medicines company, has announced its participation in the upcoming Leerink Partners Global Healthcare Conference. Ron Cooper, Chief Executive Officer, will engage in a fireside chat at the conference, which is scheduled for Tuesday, March 11, 2025, at 1:00 p.m. ET in Miami, FL.

Interested parties can access a live webcast of the presentation through the 'Investors' section of enGene's website at www.engene.com. The webcast recording will remain available on the website for 90 days following the event.

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enGene Holdings (Nasdaq: ENGN) has announced its participation in the Oppenheimer 35th Annual Healthcare Life Sciences Conference. The company's Chief Strategy and Operations Officer, Dr. Alex Nichols, will deliver a presentation at the virtual event on Tuesday, February 11, 2025, at 8:40 a.m. ET.

enGene is currently conducting a pivotal study of its non-viral lead investigational product detalimogene voraplasmid (also known as detalimogene, previously EG-70) for patients with high-risk, BCG-unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS). The presentation will be available via webcast on the company's website under the 'Investors' section and will remain accessible for 90 days.

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enGene Holdings (Nasdaq: ENGN) has granted inducement equity awards to seven newly-hired employees effective January 29, 2025. The awards consist of non-qualified stock options to purchase a total of 262,900 common shares at an exercise price of $7.39 per share, matching the closing price on the grant date.

The stock options have a 10-year term and will vest over four years, with 25% vesting after one year and the remaining vesting monthly over three years, contingent on continued employment. These grants were approved by the Company's independent Compensation Committee as employment inducements under NASDAQ Rule 5635(c)(4).

enGene is currently conducting a pivotal study of its non-viral lead investigational product detalimogene voraplasmid for high-risk, BCG-unresponsive, non-muscle invasive bladder cancer with carcinoma in situ.

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enGene Holdings (Nasdaq: ENGN) announced three poster presentations at the 2025 ASCO Genitourinary Cancers Symposium, showcasing their lead investigational product detalimogene voraplasmid. The treatment targets high-risk, BCG-unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS).

The company's pivotal LEGEND study is actively enrolling patients across the USA, Canada, Europe, and Asia-Pacific. The treatment utilizes enGene's Dually Derivatized Oligochitosan® (DDX) platform, designed to overcome viral gene therapy limitations. There are approximately 730,000 bladder cancer patients in the U.S., with 75-80% being NMIBC cases. Among high-risk NMIBC patients, 50-70% become BCG-unresponsive and experience recurrence or progression.

The presentations will cover preliminary LEGEND study results, mechanism of action details, and a phase 1/2 study of detalimogene voraplasmid intravesical monotherapy.

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enGene Holdings (Nasdaq: ENGN) announced inducement equity awards for five new employees, granted on December 27, 2024. The awards include non-qualified stock options to purchase 97,400 common shares at an exercise price of $6.42 per share, matching the closing price on the grant date. The options have a 10-year term and will vest over four years, with 25% vesting after one year and the remainder vesting monthly over three years. These grants, approved by the Company's independent Compensation Committee, serve as employment inducements under NASDAQ Rule 5635(c)(4).

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enGene Holdings (Nasdaq: ENGN) reported its financial results for FY2024 and provided business updates. The company's lead product, detalimogene voraplasmid, showed a 71% complete response rate in preliminary data from the LEGEND study's pivotal cohort for BCG-unresponsive NMIBC patients. The study is now recruiting across all four cohorts with protocol amendments including maintenance dosing.

Financial highlights include $297.9 million in cash and equivalents, providing runway into 2027. Total operating expenses were $62.3 million, up from $26.1 million in 2023. Net loss was $55.1 million ($1.46 per share) compared to $104.7 million ($151.22 per share) in 2023.

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enGene Holdings (Nasdaq: ENGN) announced its participation in two upcoming investor conferences. The company's Chief Strategy and Operations Officer, Alex Nichols, Ph.D., will present at the Virtual Citizens JMP Hematology & Oncology Summit on December 2, 2024, at 10:00 a.m. ET, and the Piper Sandler 36th Annual Healthcare Conference on December 3, 2024, at 3:00 p.m. ET.

enGene is developing detalimogene voraplasmid, a non-viral investigational product for high-risk, BCG-unresponsive, non-muscle invasive bladder cancer with carcinoma in situ. The presentations will be available via webcast on the company's website for 90 days.

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enGene Holdings (Nasdaq: ENGN) announced its participation in Guggenheim's Inaugural Healthcare Innovation Conference. CEO Ron Cooper and CMO Dr. Raj Pruthi will engage in a fireside chat on November 12, 2024, at 10:30 a.m. ET. The company's lead investigational product, detalimogene voraplasmid, is currently in a pivotal study targeting high-risk, BCG-unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ. The event will be webcast live on enGene's website and remain accessible for 90 days.

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enGene Holdings has announced a $60 million private placement financing through the sale of 6,758,311 common shares at $8.90 per share. The financing, expected to close on October 29, 2024, includes participation from notable investors like Deep Track Capital, Cormorant Asset Management, and OrbiMed. The proceeds will fund the development of detalimogene voraplasmid, their lead investigational product for bladder cancer treatment, pre-commercial activities, and platform expansion. Combined with current cash reserves, this funding is expected to sustain operations into 2027.

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FAQ

What is the current stock price of enGene Holdings (ENGN)?

The current stock price of enGene Holdings (ENGN) is $3.31 as of July 11, 2025.

What is the market cap of enGene Holdings (ENGN)?

The market cap of enGene Holdings (ENGN) is approximately 194.2M.
enGene Holdings Inc.

Nasdaq:ENGN

ENGN Rankings

ENGN Stock Data

194.20M
43.26M
13.61%
74.73%
0.12%
Biotechnology
Biological Products, (no Disgnostic Substances)
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Canada
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