Welcome to our dedicated page for enGene Therapeutics news (Ticker: ENGN), a resource for investors and traders seeking the latest updates and insights on enGene Therapeutics stock.
enGene Therapeutics Inc. develops non-viral genetic medicines for delivery to mucosal tissues and other organs. The company’s lead program is detalimogene voraplasmid, also known as detalimogene, for non-muscle invasive bladder cancer. Detalimogene is being evaluated in the multi-cohort LEGEND Phase 2 trial, including a pivotal cohort in high-risk, Bacillus Calmette-Guérin-unresponsive patients with carcinoma in situ, with or without concomitant papillary disease.
Recurring enGene news includes LEGEND clinical data, FDA designation and manufacturing-readiness updates, business and financial results, debt and equity financing activity, investor-conference participation, and corporate matters such as the completed name change from enGene Holdings Inc. to enGene Therapeutics Inc. The company’s common shares trade on Nasdaq under ENGN, and its listed warrants trade under ENGNW.
enGene Holdings (Nasdaq: ENGN), a clinical-stage, non-viral genetic medicines company, announced that CEO Ron Cooper will present at the Jefferies Global Healthcare Conference in New York City. The presentation is scheduled for June 4, 2025, at 11:05 a.m. ET. Investors can access the live webcast through the company's website at www.engene.com under the "Investors" section, where it will remain available for 90 days.
enGene Holdings (NASDAQ: ENGN) has appointed Amy Pott as Chief Global Commercialization Officer, marking the company's first dedicated executive for commercialization planning and execution. This strategic hire comes as enGene prepares to file a Biologics License Application (BLA) with the FDA in mid-2026 for detalimogene voraplasmid, their lead investigational treatment for BCG-unresponsive, non-muscle invasive bladder cancer (NMIBC).
Pott brings extensive experience from her previous roles, including Senior Vice President at Astellas Pharma, President of North America at Swedish Orphan Biovitrum, and various leadership positions at Shire and Baxalta. She holds a Master's degree from the London School of Economics and will report directly to CEO Ron Cooper.
enGene Holdings (Nasdaq: ENGN), a clinical-stage, non-viral genetic medicines company, has announced its participation in two major investor conferences in May 2025. The company will deliver presentations at:
- The 2025 Bloom Burton & Co. Healthcare Investor Conference on Monday, May 5, 2025, at 2:30 p.m. ET with a corporate presentation format
- The Citizens Life Sciences Conference on Wednesday, May 7, 2025, at 11:30 a.m. ET in a fireside chat format
Both presentations will be available via live webcast on the company's website under the 'Investors' section at www.engene.com and will remain accessible for 90 days following the events.
enGene Holdings (Nasdaq: ENGN) has announced the granting of inducement equity awards to seven newly-hired employees effective April 2, 2025. The awards comprise non-qualified stock options to purchase a total of 144,650 common shares at an exercise price of $4.44 per share, matching the closing price on the grant date.
The stock options feature a 10-year term with a four-year vesting schedule: 25% vesting after one year of employment, followed by monthly vesting over three years. These grants, approved by the Company's independent Compensation Committee, serve as employment inducements under NASDAQ Rule 5635(c)(4).
enGene Holdings (Nasdaq: ENGN), a clinical-stage, non-viral genetic medicines company, has announced its participation in the upcoming Stifel 2025 Virtual Targeted Oncology Forum. Ron Cooper, Chief Executive Officer, will deliver a presentation on Tuesday, April 8, 2025, at 4:00 p.m. ET.
The presentation will be accessible through a live webcast under the 'Investors' section of enGene's website at www.engene.com. The recording will remain available on the website for 90 days following the event.
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.
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.
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.
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.
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.