# Biopharmaceutical clinical trial developments

> Live situation record from CLSTR: https://clstr.news/situations/biopharmaceutical-clinical-trial-developments
> Updated: 2026-10-20T14:07:07.000Z. Sources: 13. Developments: 2.

NeuroScientific Biopharmaceuticals has cleared a regulatory hurdle with the U.S. Food and Drug Administration (FDA) for its phase two clinical trial of StemSmart cell therapy, intended for patients with treatment-resistant Crohn’s disease. The FDA approved the proposed study design and existing human clinical evidence, determining that no further non-clinical studies are required.

In separate developments, Bioxodes reported positive phase 2a results from its BIRCH trial for BIOX-101, an investigational therapy for spontaneous intracerebral hemorrhage. The data suggests the treatment may reduce secondary brain injury. Additionally, Neurocrine Biosciences has launched a Phase 2 clinical trial for NBI-567, a treatment targeting Alzheimer’s disease in adults with mild to moderate cognitive impairment.

## Timeline

### 2026-10-20: Bioxodes and Neurocrine Biosciences announce progress in neurological clinical trials

Bioxodes reports successful phase 2a trial results for BIOX-101 in treating intracerebral hemorrhage, while Neurocrine Biosciences begins a Phase 2 trial for its Alzheimer's candidate NBI-567.

7 sources. https://clstr.news/cluster/bioxodes-and-neurocrine-biosciences-announce-progress-in-neurological-clinical-trials

### 2026-10-13: NeuroScientific Biopharmaceuticals clears FDA hurdle for Crohn’s trial

NeuroScientific Biopharmaceuticals received positive feedback from the FDA regarding its StemSmart cell therapy for treatment-resistant Crohn’s disease, clearing a path for phase two clinical trials.

5 sources. https://clstr.news/cluster/neuroscientific-biopharmaceuticals-clears-fda-hurdle-for-crohns-trial

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Cite as: Biopharmaceutical clinical trial developments. CLSTR, https://clstr.news/situations/biopharmaceutical-clinical-trial-developments