enGene Holdings Inc. provided an update on their financial results for the third quarter of 2025 and shared key business developments.
The company achieved the target enrollment milestone for the LEGEND trial pivotal cohort in high-risk BCG unresponsive NMIBC with carcinoma in situ.
Detalimogene was granted Regenerative Medicine Advanced Therapy (RMAT) designation by the FDA, with a Biologic License Application (BLA) submission planned for the second half of 2026.
The company reported cash and marketable securities of $224.9 million, expected to provide runway into 2027.
LEGEND Trial Milestone Achieved
enGene reached the target enrollment milestone for the pivotal cohort in the LEGEND trial, a significant step in their clinical development.
RMAT Designation for Detalimogene
Detalimogene received RMAT designation from the FDA, offering regulatory advantages and validating its potential in treating high-risk bladder cancer.
Financial Stability
With $224.9 million in cash and marketable securities, enGene is well-positioned financially to support its operations and development plans.
- The achievement of the target enrollment milestone in the LEGEND trial signifies progress and momentum in enGene's gene therapy development efforts.
- The RMAT designation for Detalimogene highlights the recognition of its potential as an advanced therapy option for high-risk bladder cancer patients.
The updates provided by enGene Holdings Inc. reflect significant advancements in their clinical programs and regulatory status, positioning the company for future growth and potential commercialization of their therapies.