enGene Holdings Inc. Stock Price, News & Analysis

enGene Holdings (NASDAQ:ENGN) has reached a significant milestone in its LEGEND Phase 2 trial for detalimogene voraplasmid, achieving the target enrollment of 100 patients with high-risk, BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in-situ (CIS).

The company plans to overenroll in its pivotal cohort and has adjusted its timeline for Biologic License Application (BLA) submission to 2H 2026. An update from the LEGEND trial's pivotal cohort is expected in Q4 2025. The trial aims to develop the first non-viral gene therapy for NMIBC, focusing on balancing efficacy, safety, and ease of use.

enGene Holdings (Nasdaq: ENGN), a clinical-stage non-viral gene therapy company, has announced its participation in three major healthcare investor conferences in September 2025. The company will present at the Wells Fargo Healthcare Conference on September 3 at 8:45 a.m. ET, the H.C. Wainwright Global Investment Conference on September 8 at 1:30 p.m. ET, and the Morgan Stanley Global Healthcare Conference on September 10 at 1:50 p.m. ET.

All presentations will be available via webcast on the company's website under the "Investors" section and will remain accessible for 90 days following the events.

enGene Holdings (NASDAQ: ENGN), a clinical-stage non-viral gene-based immunotherapy company, has granted inducement equity awards to three new employees effective July 31, 2025. The awards include non-qualified stock options to purchase 93,200 common shares at an exercise price of $3.79 per share.

The stock 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 were approved by the independent Compensation Committee as employment inducements under NASDAQ Rule 5635(c)(4).

enGene Holdings (NASDAQ: ENGN) has announced significant leadership changes to support its commercial readiness, particularly for its lead therapy detalimogene. The company appointed three industry veterans to its Board of Directors: Philip Astley-Sparke, former BioVex CEO and Replimune co-founder; William Grossman, M.D., Ph.D., former Gilead Sciences SVP; and Michael Heffernan, Collegium Pharmaceutical founder.

Additionally, enGene made key management promotions: Matthew Boyd as Chief Regulatory Officer, Jill Buck as Chief Development Officer, and Katherine Chan, M.D., M.P.H. as Executive Director, Urology Clinical Lead. These appointments strengthen the company's clinical and regulatory operations as it prepares for planned regulatory filings and commercialization of its non-viral gene-based immunotherapy pipeline.

enGene (NASDAQ: ENGN) has received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA for detalimogene voraplasmid, its lead therapy for high-risk, BCG-unresponsive, non-muscle invasive bladder cancer (NMIBC). The designation was based on promising preliminary results from the LEGEND study showing compelling clinical activity and favorable tolerability.

The RMAT designation provides significant regulatory advantages, including expedited development and review process, early FDA engagement, potential rolling review, and priority review benefits. Detalimogene is designed for efficient administration in urology clinics, targeting approximately 70% of urologists who provide care in community practices.

enGene Holdings (NASDAQ: ENGN) has granted inducement equity awards to four new employees, including Chief Global Commercialization Officer Amy Pott. Ms. Pott received a non-qualified stock option to purchase 400,000 common shares, while three other employees received options for a total of 53,450 shares. All options have an exercise price of $3.31 per share, matching the closing price on June 16, 2025. The options have a 10-year term and vest over four years, with 25% vesting after one year and the remainder vesting monthly over three years. These grants were approved by the Compensation Committee as employment inducements under NASDAQ Rule 5635(c)(4).

enGene Holdings (NASDAQ: ENGN) reported Q2 2025 financial results and provided key business updates. The company's pivotal LEGEND study for detalimogene in BCG-unresponsive NMIBC with CIS is progressing well, with additional data expected in H2 2025 and BLA filing planned for mid-2026. The company appointed Amy Pott as Chief Global Commercialization Officer and received positive feedback from EMA regarding potential Conditional Marketing Authorization. Financial results showed cash position of $251.5M expected to fund operations into 2027. Q2 operating expenses increased to $27.1M from $17.3M YoY, with net loss of $25.8M ($0.51/share) compared to $15.0M ($0.38/share) in Q2 2024. The increased loss was primarily due to higher R&D expenses for the LEGEND study.

enGene Holdings (NASDAQ: ENGN), a clinical-stage non-viral genetic medicines company, announced the resignation of Chief Medical Officer Dr. Raj Pruthi effective June 16, 2025. Dr. Pruthi submitted his resignation on June 3, 2025, and will assist in transitioning his responsibilities before his departure. The company plans to redistribute his duties among its existing team of urology and clinical experts. This management change comes as the company continues its work in the non-viral genetic medicines space.

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.