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BOSTON & MONTREAL - enGene Holdings Inc. (NASDAQ: ENGN), a biotechnology company focusing on non-viral genetic medicines, has announced the appointment of Amy Pott as Chief Global Commercialization Officer. Ms. Pott will be the first to hold this position at enGene, tasked with leading the commercialization efforts of the company’s products, including the anticipated launch of detalimogene voraplasmid, their lead investigational agent for treating non-muscle invasive bladder cancer (NMIBC).
Ms. Pott’s extensive background includes senior roles at Astellas Pharma, Swedish Orphan Biovitrum, and Shire, with a strong focus on gene therapies and rare diseases. Her expertise is expected to be a significant asset to enGene as they prepare for the submission of a Biologics License Application (BLA) to the FDA in mid-2026. This submission will follow the completion of the pivotal cohort of the LEGEND trial.
Detalimogene voraplasmid is currently under evaluation in the LEGEND Phase 2 study for patients with BCG-unresponsive NMIBC. The investigational medicine has been developed using enGene’s proprietary Dually Derivatized Oligochitosan (DDX) platform, which aims to improve the delivery and efficacy of gene therapies. Analysts maintain a bullish outlook on the company’s prospects, with price targets ranging from $7 to $34 per share. The FDA has granted Fast Track designation to detalimogene voraplasmid due to its potential to meet an unmet medical need for patients with BCG-unresponsive carcinoma in situ (CIS) NMIBC.
enGene’s CEO, Ron Cooper, expressed enthusiasm about Ms. Pott joining the team, citing her leadership and successful track record. In response, Ms. Pott conveyed her excitement about contributing to enGene’s mission and advancing the treatment landscape for bladder cancer patients.
This press release contains forward-looking statements regarding enGene’s plans and expectations for future developments, including the timing of the BLA submission and the results of the LEGEND study. These statements are based on the management’s current expectations and are subject to risks and uncertainties that could cause actual results to differ materially. The company maintains a healthy balance sheet with a current ratio of 17.16 and minimal debt-to-equity of 0.1. Investors can access detailed financial metrics, extensive company analysis, and more through InvestingPro, which offers over 30 additional premium insights for enGene.
The information in this article is based on a press release statement from enGene Holdings Inc.
In other recent news, Engene Holdings Inc. has garnered attention from analysts with its promising developments in the treatment of high-risk non-muscle invasive bladder cancer (HR-NMIBC). Citizens JMP reiterated its Market Outperform rating for Engene, maintaining a price target of $18.00. This outlook is supported by the company’s progress in developing detalimogene, a product aimed at treating BCG-unresponsive NMIBC. The firm’s analyst emphasized the significance of upcoming data from the LEGEND cohort, which is expected to provide critical insights into the treatment landscape.
Similarly, H.C. Wainwright maintained a Buy rating for Engene Holdings, with a higher price target of $25.00. Their analyst, Andres Maldonado, highlighted the encouraging early results from the LEGEND study, noting a 71% complete response rate at any time and a 47% rate at six months. These figures compare favorably to recent drug approvals in the same category. The company plans to release further updates in the second half of 2025, with a final data readout and a Biologics License Application submission anticipated in 2026.
Both analyst firms recognize the potential impact of Engene’s detalimogene voraplasmid in addressing unmet medical needs for HR-NMIBC patients. Investors are keeping a close watch on these developments as the company advances its pipeline of innovative treatments.
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