FDA Feedback Clears Key Hurdles for NeuroScientific’s Crohn’s Trial
NeuroScientific reported positive FDA feedback on its planned Phase 2 StemSmart trial for treatment-resistant Crohn’s disease, with favourable responses to six of seven questions and no additional non-clinical studies required. The company has appointed Southern Star Research to run the trial in Australia and the US, targeting a start by year-end, while manufacturing transfer and preparation for a TGA inspection continue. Its name change to Miro Sciences is due to take effect on 28 October.
Closing price · 2026-10-27: $0.054 · +3.85%