Neurogene (NGNE) said Monday that the US Food and Drug Administration has allowed the company to continue an early-stage trial using a lower dose of NGN-401, the company's intended gene therapy for Rett syndrome, a rare genetic neurological disorder.
The company said it had paused the higher-dose cohort of the study following a previously disclosed emerging treatment-related serious adverse event in a trial participant. It also said it does not plan to enroll any more participants at the higher-dose level.
So far, the company said it had not received reports of other treatment-related serious adverse events in the trial. However, it said that it no longer expects to complete enrollment of participants in the low-dose cohort in Q4.
Shares of the company fell more than 18% in premarket activity.
Price: 28.00, Change: -6.51, Percent Change: -18.88
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