Neurogene’s NGN-401 Granted RMAT Status for Rett Syndrome

Neurogene (NGNE) has provided an update.

Neurogene Inc. has recently announced that the FDA awarded its gene therapy drug, NGN-401, the coveted RMAT designation for treating Rett syndrome, indicating its significant potential in meeting the unmet medical needs for this condition. This status not only brings the benefits of Fast Track and Breakthrough Therapy designation, such as frequent FDA interactions and guidance on drug development but also opens the door to an Accelerated Approval pathway and Priority Review, which could expedite NGN-401’s availability to patients.

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