Highlights

  • NeuroScientific Biopharmaceuticals shares rose 11.70% to AUD 0.10 on 26 May 2026.
  • The company reported favourable outcomes from its Special Access Program using StemSmart for fistulising Crohn’s disease patients.
  • Five patients received treatment, with all showing improvement and 4 out of 5 patients achieving a successful Clinical Response.
  • No serious adverse events were reported during treatment.
  • NeuroScientific has initiated development of a Phase 2 clinical trial in Australia targeting fistulising Crohn’s disease.
  • The planned Phase 2 trial is expected to commence in the second half of calendar year 2026.
  • The global Crohn’s disease market is estimated at approximately US$13 billion.

NeuroScientific Biopharmaceuticals Ltd (ASX:NSB) shares climbed 11.70% to AUD 0.10 during the morning session on 26 May 2026 after the biotechnology company released favourable clinical outcomes from patients treated with its StemSmart mesenchymal stem cell therapy under a Special Access Program.

The stock has now gained approximately 110% over the past year, with investors appearing to respond positively to the company’s latest update involving patients with fistulising Crohn’s disease, a severe and difficult-to-treat inflammatory bowel disease complication.

The announcement highlighted that four out of five treated patients achieved a successful Clinical Response, while all patients reportedly showed some level of improvement following treatment with StemSmart.

The update also marked the completion of the company’s Special Access Program and the beginning of preparations for a dedicated Australian Phase 2 clinical trial.

Positive Clinical Outcomes Reported in Special Access Program

NeuroScientific stated that five patients between the ages of 18 and 49 received StemSmart therapy under the Therapeutic Goods Administration’s Special Access Scheme Category B pathway.

According to the company, all five patients responded to treatment, while four patients achieved what was classified as a successful Clinical Response.

The company defined Clinical Response as either:

  • closure of at least 50% of fistula openings; or
  • a reduction of at least 50% in fistula discharge.

The assessments were conducted by treating physicians or qualified investigators.

The remaining patient reportedly demonstrated a partial response but did not meet the required threshold for classification as a Clinical Response.

Importantly, NeuroScientific confirmed that no serious adverse events were observed during treatment, with the therapy described as safe and well tolerated.

The patients involved in the program were described as younger adults living with fistulising Crohn’s disease who had limited treatment Options available and were resistant to currently approved therapies.

Improvements Recorded Across Multiple Assessment Measures

Beyond the primary Clinical Response measurements, the company stated that patients also showed improvement across several internationally recognised Crohn’s disease scoring systems.

These included:

  • Crohn’s Disease Activity index (CDAI)
  • Perianal Disease Activity Index (PDAI)
  • Inflammatory Bowel Disease Questionnaire (IBDQ) Quality of Life Index

NeuroScientific indicated that radiological imaging using MRI scans also demonstrated trends toward fistula healing in all treated patients, although the company noted that the timing of assessments was considered too early to confirm complete fistula closure through imaging alone.

Another notable outcome involved the removal of setons in all patients.

Setons are surgical implants used to assist fistula drainage and reduce infection risk. According to the company, each patient had at least one seton removed following treatment, which management described as a significant indicator of healing progression.

Company Preparing for Phase 2 Clinical Trial

Following the completion of the Special Access Program, NeuroScientific confirmed that it has initiated development activities for a dedicated Phase 2 clinical trial targeting fistulising Crohn’s disease patients in Australia.

The company stated that insights gained from the Special Access Program and earlier StemSmart clinical work will help shape the design of the upcoming study.

Areas expected to be informed by the earlier data include:

  • dosing schedules
  • induction considerations
  • timing of MRI assessments

The Australia-focused Phase 2 study is anticipated to commence during the second half of calendar year 2026.

According to the company, the planned trial is intended to generate pivotal clinical data supporting future Marketing Authorisation efforts in Australia.

NeuroScientific also confirmed that this study will run in parallel with its previously announced broader Phase 2 trial involving refractory Crohn’s disease patients across Australia and the United States.

StemSmart Positioned as Platform Cell Therapy

StemSmart is NeuroScientific’s patented stem cell technology derived from adult human donor bone marrow mesenchymal stem cells.

The company stated that the therapy is manufactured using a proprietary process designed to improve therapeutic activity and clinical response.

Management described StemSmart as a platform cell therapy with potential applications extending beyond Crohn’s disease into other inflammatory and immune-related conditions.

Potential future areas of focus highlighted by the company include:

  • organ transplant immune tolerance
  • lung inflammatory diseases
  • graft-versus-host disease (GvHD)

The company believes these areas represent significant unmet medical needs where inflammatory processes play a major role.

Crohn’s Disease Market Opportunity Remains Significant

NeuroScientific also used the announcement to highlight the broader commercial opportunity associated with Crohn’s disease therapies.

According to the company, the global Crohn’s disease market is estimated to be worth approximately US$13.8 billion by 2026.

The company suggested that the latest Special Access Program results provide an early foundation for future commercial positioning within this market.

NeuroScientific also referenced several additional target markets relevant to StemSmart, including:

  • organ transplant immunosuppressants
  • inflammatory lung disorders
  • graft-versus-host disease treatments

These broader therapeutic areas collectively represent multi-billion-dollar global markets according to figures referenced by the company.

Management Commentary Reflects Confidence in Early Results

Chief Medical Officer Dr Cathy Cole described the Clinical Response rate as exceptional, particularly given the severity and long-standing nature of the patients’ conditions.

Management also highlighted that the patients involved in the program had very limited treatment alternatives available before receiving StemSmart therapy.

The company indicated that the positive outcomes provide confidence moving into formal Phase 2 trial development, particularly regarding treatment frequency, dosing schedules, and imaging assessments.

Chief Executive Officer Nathan Smith stated that the Special Access Program results highlighted the opportunity to conduct a dedicated Australian clinical trial focused on fistulising Crohn’s disease.

Management also noted that the planned study may assist in accelerating the pathway toward future commercialisation and potential regulatory approvals.

Meanwhile, Non-Executive Chairman Robert McKenzie said the results reinforced the company’s commitment to advancing StemSmart development for difficult-to-treat patient groups.

Company Continues Expanding Biotechnology Focus

NeuroScientific Biopharmaceuticals is an Australian biotechnology company focused on therapies targeting immune-mediated inflammatory diseases.

The company’s research activities centre around chronic and degenerative conditions where existing treatment options may demonstrate limited effectiveness or durability.

In addition to StemSmart, NeuroScientific is also progressing development work involving EmtinB, a peptide-based compound designed to support neuroprotection, neuroregeneration, and modulation of neuroinflammation.

The company’s broader strategy remains focused on advancing biologic therapies aimed at addressing unmet clinical needs across several inflammatory and neurological disease categories.

What This Means for Investors

Today’s share price rise suggests investors responded favourably to NeuroScientific’s latest clinical update and the reported outcomes from the Special Access Program.

The combination of an 80% Clinical Response rate, no serious adverse events, and progression toward Phase 2 trials appears to have strengthened market interest in the company’s StemSmart program.

The update also potentially improves visibility around the company’s regulatory and commercial development pathway, particularly in Australia.

At the same time, biotechnology development remains inherently complex, with future progress dependent on larger Clinical Trials, regulatory outcomes, and longer-term efficacy and safety data.

Nevertheless, the latest announcement represents an important operational milestone for NeuroScientific as it advances StemSmart toward broader clinical evaluation.