enGene Holdings Inc.
7.33-0.58 (-7.33%)
Oct 29, 4:00:00 PM EDT · NasdaqCM · ENGN · USD
Key Stats
Market Cap
375.24MP/E (TTM)
-Basic EPS (TTM)
-1.90Dividend Yield
0%Recent Filings
8-K
enGene names new CMO
enGene Holdings appointed Dr. Hussein Sweiti as Chief Medical Officer effective September 29, 2025, bringing his 15+ years of oncology expertise, including leading Johnson & Johnson's recent FDA approval for bladder cancer treatment. This bolsters clinical strategy as the company eyes a BLA submission for detalimogene in the second half of 2026, following target enrollment in its pivotal LEGEND trial. Sweiti's regulatory savvy sharpens focus on commercialization. Yet risks like trial delays loom.
8-K
enGene hits LEGEND enrollment milestone
enGene Holdings hit target enrollment of 100 patients in the pivotal cohort of its Phase 2 LEGEND trial for detalimogene in high-risk, BCG-unresponsive NMIBC with CIS, while securing FDA RMAT designation for regulatory perks like priority review. Cash reserves stand at $224.9 million, funding operations into 2027 despite Q3 net loss of $28.9 million from ramped R&D costs. BLA submission is eyed for 2H 2026. Momentum builds, yet trial risks loom.
10-Q
Q3 FY2025 results
enGene Holdings posted a $29.0M net loss for Q3 FY2025 ended July 31, 2025, up 105% y/y from $14.1M, driven by R&D expenses doubling to $22.6M on ramped-up manufacturing and clinical work for its lead detalimogene program in BCG-unresponsive NMIBC. Operating loss widened to $29.9M, 79% higher y/y, while diluted EPS slipped to -$0.57 from -$0.32, consistent with 51.1M weighted shares. Cash burn accelerated with $74.3M used in operations YTD, leaving $32.6M in cash equivalents and $192.3M in marketable securities against $23.1M debt due mostly in 2026 at 11.63% effective rate; free cash flow not disclosed in the 10-Q. Yet cash runway extends at least 12 months per management. Regulatory hurdles loom large in advancing the pivotal LEGEND trial.
8-K
enGene reaches 100-patient milestone in LEGEND trial for detalimogene in high-risk NMIBC with CIS; BLA submission targeted for 2H 2026.
enGene Holdings Inc. (Nasdaq: ENGN) announced achieving target enrollment of 100 patients in the pivotal cohort of its Phase 2 LEGEND trial for detalimogene voraplasmid in high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in-situ (CIS). The trial evaluates detalimogene in BCG-unresponsive patients, with potential over-enrollment. The company plans a BLA submission in 2H 2026.
8-K
Board and leadership refresh
enGene Holdings bolstered its board and leadership on July 7-8, 2025, with Jasper Bos resigning amicably and Philip Astley-Sparke, William Grossman, and Michael Heffernan joining to guide commercialization of detalimogene for bladder cancer. Management promotions elevated Matthew Boyd to Chief Regulatory Officer and Jill Buck to Chief Development Officer, strengthening clinical and regulatory expertise. These moves signal enGene's pivot toward regulatory filings. Yet risks like trial enrollment persist.
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