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

Neurogene

27/02/2026 11:56

** 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

 (Reporting by Kunal Das in Bengaluru)

 ((Kunal.Das2@thomsonreuters.com;))