EnGene Says US FDA Selects Detalimogene for Manufacturing Pilot Program

MT Newswires Live12-02

EnGene (ENGN) said Tuesday that the US Food and Drug Administration selected detalimogene for its chemistry, manufacturing and controls development and readiness pilot program.

Detalimogene is an investigational non-viral gene therapy for high-risk, non-muscle invasive bladder cancer, the company said.

The pilot is designed to support CMC readiness for therapies with compressed clinical timelines, giving companies earlier and more structured engagement with the regulator, EnGene said.

The pilot program will provide additional interactions with the FDA ahead of a planned biologics license application submission in H2 of next year, the company said.

Shares of the company were up more than 2% in recent Tuesday premarket activity.

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