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Wire · regulatory

NeuroScientific locks in key US FDA meeting

13 August 2026 · By · Wire by Fusion42

Published

13 August 2026

Topic

regulatory

◆ Sectors

Biotech

◆ Geography

United States

◆ Source

Read at smh.com.au →

◆ Verified

Fusion42 · 13 August 2026 · Fusion42 review

Perth-based NeuroScientific Biopharmaceuticals secured a Pre-IND meeting with the US FDA to discuss their StemSmart stem cell therapy for refractory Crohn’s disease, advancing regulatory steps towards a Phase 2 trial in the US market.

This Wire brief sits within Fusion42's coverage of Biotech.

◆ ◆ The Wire takeaway

You face a clear path to US market entry if you’re developing regenerative therapies for chronic diseases. NeuroScientific’s FDA engagement opens the door for stem cell treatments against refractory illnesses, signalling commercial potential beyond local markets.

◆ Coverage

1 source · 13 Aug 2026

◆ Related on Wire

◆ Topics

Biotechfdaclinical-trialscrohns-diseasestem-cell-therapybiotech-us-market