Biotechnology company enGene Inc reported on Thursday the receipt of the US Food and Drug Administration's (FDA) Fast Track Designation for EG-70 for the treatment of patients with Bacille Calmette-Guerin (BCG)-unresponsive non-muscle invasive bladder cancer.
According to the company, EG-70 is its lead investigational non-viral gene therapy for the treatment of patients with Bacille Calmette-Guerin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC).
The company said the therapeutic programmes that receive Fast Track Designation can benefit from more frequent communication with the FDA, eligibility for Priority Review and Accelerated Approval, and potentially for Rolling Review of the marketing application.
Following the US FDA's recognition of the company's EG-70 programme, it now looks forward to working closely with the USFDA throughout the clinical development process to bring this innovative treatment to patients as quickly as possible, added CEO Jason Hanson.
Sanofi receives FDA orphan drug designation for riliprubart in transplant rejection
Hoth Therapeutics reports positive interim results for HT-001 topical therapy
Breckenridge Pharmaceutical's generic for Ablysinol granted final FDA approval
Hemab Therapeutics presents bleeding disorder clinical and preclinical data at ISTH 2025 Congress
Cumberland Pharmaceuticals reports ifetroban Phase 2 DMD heart disease trial results
Sarclisa recommended for EU approval in newly diagnosed transplant-eligible multiple myeloma
FDA approves Dupixent as first targeted therapy for rare skin disease bullous pemphigoid