enGene Holdings Inc. (ENGN)

Over the past six months, enGene Holdings, Inc. stock has experienced several notable events. The stock trended up by 81.84% in the past six months, despite a 16.04% decline over the past year. In November 2025, enGene announced the pricing of a $130 million public offering of common shares and pre-funded warrants and reported additional preliminary data from its LEGEND pivotal cohort, demonstrating an improved complete response rate of 62% at 6 months. Several analysts raised their price targets for enGene in November 2025, contributing to a consensus "Moderate Buy" rating. In September 2025, enGene reported a wider-than-expected net loss for the third quarter, leading to a decline in shares. In June 2025, the U.S. FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to detalimogene. In July 2025, enGene announced the appointment of three new members to its Board of Directors and promotions within its management team.

As enGene Holdings, Inc. is a clinical-stage biotechnology company, traditional demand seasonality for products and services is not applicable. The company's focus is on research, development, and advancing its clinical pipeline towards regulatory approval.

enGene Holdings, Inc. is a clinical-stage biotechnology company focused on developing innovative gene therapies and advanced drug delivery systems, specializing in non-viral genetic medicines delivered directly to mucosal tissues and other organs. The company's primary mission is to enhance the quality of life for individuals with urological cancers, particularly non-muscle invasive bladder cancer (NMIBC). Their lead product candidate is EG-70 (detalimogene voraplasmid), a non-viral immunotherapy designed to treat high-risk NMIBC patients who have not responded to Bacillus Calmette-Guérin (BCG) treatment. enGene's business model integrates research and development, strategic partnerships, and future commercialization, with anticipated revenue from product sales, licensing agreements, and collaborations once products are commercialized. As of recent reports, the company has not yet generated product revenue.

enGene Holdings, Inc. is headquartered in Saint-Laurent, Canada, and maintains office space in Waltham, Massachusetts. The company has expanded its clinical trial footprint for its LEGEND study to include sites in Europe and Asia, indicating a growing international reach for its clinical development activities.

enGene Holdings, Inc.'s brand reputation is primarily influenced by its scientific credibility, clinical trial progress, and investor confidence. The company's reputation has been positively impacted by promising clinical trial results for detalimogene voraplasmid and the granting of Regenerative Medicine Advanced Therapy (RMAT) designation by the FDA. Analyst upgrades and increased price targets further reflect positive sentiment within the investment community. Despite positive clinical progress, the company's reputation among some investors faced a challenge in September 2025 when it reported a wider-than-expected Q3 loss, leading to a stock decline. An update in November 2025 revealed that earlier patients in the LEGEND study experienced a lower 12-month complete response rate compared to FDA-approved therapies, leading to an amended primary clinical endpoint after discussions with the FDA.

The ownership structure of enGene Holdings, Inc. is distributed among various investor types. Private equity firms hold the largest share, owning approximately 38% of the company. Institutions hold about 28.3% of the shares, while VC/PE firms account for 49.5%. Hedge funds own approximately 7.73% of the shares, and the general public holds about 13.8%. Individual insiders own a smaller portion, around 0.689%. Shareholders have experienced dilution in the past year, with total shares outstanding growing by 26.7%.