Neuren Pharma shares soar on progress for new drug trial
Make us a preferred source
Make us a preferred source on Google
The news: Shares in Neuren Pharmaceuticals have jumped after the company said it is on track for a clinical trial of a new drug following a productive meeting with the US regulator.
The numbers: Neuren said the US Food and Drug Administration (FDA) approved the primary endpoints for a Phase 3 trial of drug NNZ-2591, which is intended to treat hypoxic-ischemic encephalopathy (HIE).
Neuren shares were up 16% to $10.68 in early trading on the ASX.
The context: Neuren said alignment with the FDA was previously reached on the other key features of the Phase 3 program. The company remains on track to start the Phase 3 trial by mid-year 2025 and it anticipates NNZ-2591 in HIE will qualify for orphan drug and rare paediatric disease designations. The start date of the trial is subject to a final FDA review of the trial’s protocols.
“We are very pleased with the outcome of another constructive discussion with the [FDA] and are now excited to be able to move forward as planned with the first-ever phase 3 trial in children with Phelan-McDermid syndrome,” CEO Jon Pilcher told investors.
The source: ASX
