“We continue to demonstrate strong execution, with completion of enrollment in the Embolden registrational trial, dosing more than half of participants, and receipt of Breakthrough Therapy designation for NGN-401,” stated Rachel McMinn, Ph.D., Founder and Chief Executive Officer of Neurogene (NGNE). “NGN-401 continued to be generally well-tolerated at the 1E15 vg dose, and we remain on track to complete dosing in the second quarter of 2026. With PPQ planned to begin mid-year and early commercial-readiness activities well underway, we believe NGN-401 is increasingly de-risked as we advance toward a BLA submission and potential launch of NGN-401.”
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