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Miro clears TGA audit ahead of Crohn’s disease trial

The audit clears the way for scale-up of StemSmart production and a phase II trial, after early data showed a 78% clinical response rate.

Miro Sciences has cleared a TGA manufacturing hurdle for its Crohn’s trial, with the regulator inspecting its partner’s facility ahead of a planned Phase 2 study for its StemSmart cell therapy.

4 Articles

Sydney Morning HeraldSydney Morning Herald
+3 Reposted by 3 other sources
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Miro clears TGA audit ahead of Crohn’s disease trial

Miro Sciences has cleared a TGA manufacturing hurdle for its Crohn’s trial, with the regulator inspecting its partner’s facility ahead of a planned Phase 2 study for its StemSmart cell therapy.

·North Sydney, Australia
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Sydney Morning Herald broke the news in North Sydney, Australia on Thursday, November 12, 2026.
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