enGene Holdings Inc. Stock Price, News & Analysis

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.

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.