Neurogene jumps after FDA's breakthrough tag for neurological disorder therapy

Shares of drug developer Neurogene NGNE.O rise about 28% to $25.13 premarket

Co says the U.S. FDA granted breakthrough therapy status to its experimental gene therapy, NGN-401, for a rare neurological disorder

The breakthrough tag is meant to speed up development and review of drugs to treat a serious condition or unmet medical need

NGN-401 is being tested as a one-time treatment for Rett syndrome, a rare disorder starting in infancy, causing loss of speech and movement, seizures and breathing problems

Co says FDA decision was based on interim early-stage trial data showing meaningful, lasting improvements across multiple areas of daily function

Expects to complete dosing in its registrational study in Q2 2026; plans to release additional interim data in mid-2026

NGNE shares were down over 9% in 2025