NeuroScientific Biopharmaceuticals (ASX:NSB) Receives Positive FDA Pre-IND Feedback

Aditi Sarkar

27 October 2026 10:29 PM AEDT

NeuroScientific Biopharmaceuticals (ASX:NSB) Receives Positive FDA Pre-IND Feedback

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Highlights

FDA gave favourable responses to 6 of 7 key pre-IND questions for StemSmart.
Southern Star Research appointed to run the Phase 2 refractory Crohn's trial.
Company to be renamed Miro Sciences Ltd from 28 October 2026.
Cash of $3.911 million, with an estimated runway of 5.44 quarters.

NeuroScientific Biopharmaceuticals Limited (ASX:NSB) has released its quarterly activities report and Appendix 4C for the period ended 30 September 2026. The company is advancing its StemSmart cell therapy towards a Phase 2 trial in refractory Crohn's disease.

FDA Feedback and Trial Preparation

After the quarter, the company reported that the US FDA gave favourable responses to six of seven key questions at a pre-IND meeting for the planned Phase 2 trial. The FDA agreed no additional non-clinical studies were needed. The remaining item relates to manufacturing testing and is expected to have minimal impact on timing.

Southern Star Research has been appointed to run the Phase 2 trial in Australia and the US, with initiation targeted by the end of calendar 2026. CEO Nathan Smith said the outcome confirms the StemSmart program meets FDA standards.

Manufacturing and Clinical Programs

The transfer of StemSmart manufacturing to Q-Gen Cell Therapeutics is in its validation phase, with data to be reviewed during a TGA inspection in October 2026. Completion is expected in the second half of 2026.

An open-label early-phase trial in fistulising Crohn's disease is also being developed, supported by results from the Special Access Scheme.

Corporate and Finances

Shareholders approved changing the company's name to Miro Sciences Ltd, with the proposed ticker MSX, effective 28 October 2026. In.Corp Audit and Assurance was appointed as auditor.

Cash was $3.911 million at 30 September 2026, after net operating outflows of $719,000. The company estimates a funding runway of about 5.44 quarters.

Key Takeaways

Positive FDA feedback supports the planned Phase 2 Crohn's trial.
A clinical trial partner is now in place for Australia and the US.
The company will trade as Miro Sciences from 28 October 2026.
Manufacturing transfer depends on validation and the TGA inspection.

FAQs

Q: What is StemSmart?

A: A cell therapy being developed for Crohn's disease.

Q: What did the FDA say?

A: It gave favourable responses to six of seven key pre-IND questions.

Q: Who will run the Phase 2 trial?

A: Southern Star Research.

Q: What is the company's new name?

A: Miro Sciences Ltd, with the proposed ticker MSX.

Q: What is the company's cash position?

A: $3.911 million at 30 September 2026.

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