Posted: 10 February 2025
Neuren Pharmaceuticals (ASX: NEU) today announced that the US Food and Drug Administration (FDA) has granted a Type C Meeting to discuss the primary efficacy endpoints in Neuren’s planned pivotal Phase 3 clinical trial program for NNZ-2591 to treat Phelan-McDermid syndrome. Neuren previously announced the positive outcomes from a Type B End of Phase 2 Meeting, at which alignment with FDA was reached on the other key features of the Phase 3 clinical trial program. A Type C Meeting was considered by FDA as the best forum for completion of the remaining efficacy endpoints discussion. The meeting will take place face-to-face in early April.
Neuren CEO Jon Pilcher commented: “We look forward to another constructive discussion with FDA. Having a confirmed Type C meeting now establishes a clear timetable and in parallel we are continuing all our preparations, planning for mid-year commencement of the first ever Phase 3 trial for children with Phelan-McDermid syndrome.”
