STOCK TITAN

Notifications

Limited Time Offer! Get Platinum at the Gold price until January 31, 2026!

Sign up now and unlock all premium features at an incredible discount.

Read more on the Pricing page

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.

Rhea-AI Summary

enGene (Nasdaq: ENGN) announced that the FDA selected detalimogene voraplasmid for the Chemistry, Manufacturing, and Controls Development and Readiness Pilot (CDRP) Program to support CMC interactions ahead of a potential Biologics License Application.

Detalimogene is an investigational non-viral gene therapy for high-risk, non-muscle invasive bladder cancer (NMIBC). The company says manufacturing has been scaled to commercial level and a BLA is planned for 2H 2026. Recent LEGEND pivotal-cohort data showed a 62% complete response rate at six months and safety data from 125 patients reported 42% treatment-related adverse events and 1.6% dose interruptions. Detalimogene holds RMAT and Fast Track designations.

Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
-0.63%
Tags
none
-
Rhea-AI Summary

enGene (Nasdaq: ENGN) announced that Alex Nichols, Ph.D., Chief Strategy and Operations Officer, will present at the Piper Sandler 37th Annual Healthcare Conference on Tuesday, December 2, 2025 at 12:10 p.m. ET.

A live webcast of the presentation will be available on the company’s Investors > Events and Presentations page at www.engene.com and the archive will remain accessible for 90 days.

Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
4.05%
Tags
none
-
Rhea-AI Summary

enGene (NASDAQ: ENGN) priced an underwritten public offering to raise approximately $130 million of gross proceeds through the sale of 12,558,823 common shares at $8.50 per share and 2,735,295 pre-funded warrants at $8.4999 each, before underwriting discounts and commissions. The offering includes a 30-day underwriter option to purchase up to 2,294,117 additional common shares. Closing is expected on or about November 14, 2025, subject to customary conditions. The securities will be offered under enGene’s effective Form S-3 shelf registration.

Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
-2.88%
Tags
Rhea-AI Summary

enGene (Nasdaq: ENGN) announced on November 12, 2025 that it has commenced an underwritten public offering of its common shares, with all shares to be sold by the company.

The company said it intends to grant underwriters a 30-day option to purchase up to 15% additional shares on the same terms. Jefferies, Leerink Partners and Wells Fargo Securities are joint book-running managers. The offering is made under the company’s effective Form S-3 shelf registration (File No. 333-283201). The final terms will be disclosed in a prospectus supplement filed with the SEC.

Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
-1.59%
Tags
-
Rhea-AI Summary

enGene (Nasdaq: ENGN) reported preliminary Phase 2 LEGEND pivotal-cohort data for detalimogene in high-risk, BCG-unresponsive NMIBC with CIS on November 11, 2025. Key interim results include a 63% complete response (CR) rate any time (N=62), 56% CR at 3 months (N=62), and 62% CR at 6 months (N=37). The Company completed pivotal enrollment at 125 patients, exceeding target by 25%.

Safety was favorable: 42% experienced a treatment-related adverse event (mainly Grade 1/2), 1.6% had dose interruptions, and 0.8% discontinued for TRAEs. enGene plans a BLA filing in H2 2026 with potential approval in 2027.

Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
46.76%
Tags
none
-
Rhea-AI Summary

enGene (Nasdaq: ENGN) will host a live conference call and webcast on November 11, 2025 at 8:00 a.m. ET to present new preliminary data from the pivotal cohort of the ongoing LEGEND trial for detalimogene voraplasmid in high‑risk, BCG‑unresponsive non‑muscle invasive bladder cancer with carcinoma in situ.

Registration is required to receive dial‑in details; a live webcast link and a slide deck (posted ~30 minutes before the call) will be available on the company’s Events and Presentations page. A replay of the webcast will be accessible on the company website for one year.

Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
-0.83%
Tags
conferences
Rhea-AI Summary

enGene (Nasdaq: ENGN) announced management will participate in three investor conferences in November 2025: Guggenheim 2nd Annual Healthcare Innovation Conference on Nov 11, 2025 at 12:30 p.m. ET, Stifel 2025 Healthcare Conference on Nov 12, 2025 at 2:00 p.m. ET, and Jefferies Global Healthcare Conference in London on Nov 18, 2025 at 8:30 a.m. GMT / 3:30 a.m. ET.

A live webcast of all presentations will be accessible in the Investors section of enGene's website and archived there for 90 days.

Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
0.66%
Tags
conferences
-
Rhea-AI Summary

enGene (Nasdaq: ENGN) was named to BioSpace’s 2026 Best Places to Work, one of 50 U.S. life‑science employers recognized for culture, career growth and innovation.

The company highlights its mission to advance non‑viral genetic medicines, specifically its late‑stage gene therapy detalimogene voraplasmid (detalimogene, previously EG‑70), being studied in the multi‑cohort Phase 2 LEGEND trial including a pivotal cohort for high‑risk, BCG‑unresponsive, non‑muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS).

This award follows enGene’s June selection as BIOTECanada’s 2025 Biotech Company of the Year, and the company cites the recognition as affirming its purpose‑driven culture and talent attraction efforts.

Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
-5.64%
Tags
none
-
Rhea-AI Summary

enGene Holdings (NASDAQ: ENGN), a clinical-stage non-viral genetic medicines company, has announced inducement equity awards for four new employees, including Chief Medical Officer Hussein Sweiti, M.D., MSc. The grants were made on September 30, 2025.

Dr. Sweiti received options to purchase 600,000 common shares, while three other employees received options for 57,950 shares. All options have an exercise price of $6.83 per share, matching the closing price on the grant date. The options have a 10-year term with a four-year vesting schedule: 25% after one year and the remainder vesting monthly over three years.

Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
11.27%
Tags
none
Rhea-AI Summary

enGene Holdings (NASDAQ: ENGN) has appointed Dr. Hussein Sweiti as Chief Medical Officer, effective September 29, 2025. Dr. Sweiti, a surgical oncologist with over 15 years of experience, joins from Johnson & Johnson where he was Global Medical Head of Oncology Clinical Development and played a key role in securing FDA approval for a bladder cancer treatment.

Dr. Sweiti will oversee enGene's global clinical development strategy for detalimogene, their lead candidate for non-muscle invasive bladder cancer (NMIBC). His appointment comes at a crucial time as enGene prepares for a planned BLA submission in the second half of 2026, following the completion of target enrollment in detalimogene's pivotal NMIBC clinical trial.

Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
5.89%
Tags
none

FAQ

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

The current stock price of enGene Holdings (ENGN) is $8.07 as of December 5, 2025.

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

The market cap of enGene Holdings (ENGN) is approximately 549.7M.
enGene Holdings Inc.

Nasdaq:ENGN

ENGN Rankings

ENGN Stock Data

549.69M
57.42M
13.63%
89.73%
0.03%
Biotechnology
Biological Products, (no Disgnostic Substances)
Link
Canada
SAINT-LAURENT