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 (Nasdaq: ENGN) reported full‑year 2025 results and a business update on December 22, 2025. Key operational highlights include completion of enrollment in the LEGEND pivotal cohort at 125 patients and preliminary post‑amendment 6‑month complete response (CR) rate of 62% (n=37). The company was selected for the FDA CDRP program to support CMC readiness and plans a BLA filing in 2H 2026 for detalimogene.
Financially, enGene held $202.3M cash and marketable securities as of Oct 31, 2025 and raised $140.1M net in November, giving runway into 2H 2028. Full‑year operating expenses rose to $123.2M with a net loss of $117.3M (−$2.29/share).
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.
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.
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.
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.
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.
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.
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.
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.
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.