Latest Stem Cell Therapies News

The US FDA has supported six of seven elements NeuroScientific Biopharmaceuticals put forward for its planned StemSmart Phase 2 Crohn’s disease trial. The remaining issue is a manufacturing control for viral contamination, while trial commencement remains targeted for the end of 2026 and subject to further requirements.

NeuroScientific Biopharmaceuticals (ASX:NSB) has locked in a key FDA Pre-IND meeting for late August, advancing its Phase 2 trial plans for StemSmart™ targeting refractory Crohn’s disease in the US and Australia.

Mesoblast delivered US$115 million in Ryoncil® revenue in its first full year post-FDA approval, while expanding clinical trials into adult indications and acquiring cutting-edge CAR technology to boost its cell therapy pipeline.

Mesoblast Limited’s Ryoncil® posted US$36 million in Q4 revenue, driving a full-year total of US$115 million, exceeding initial forecasts. The FDA-approved stem cell therapy for pediatric graft-versus-host disease shows robust uptake across US pediatric centres.

Cynata Therapeutics secures a crucial regulatory green light from the EMA’s Paediatric Committee for its CYP-001 treatment in children with acute graft versus host disease, paving the way for sequential adult and paediatric trials in Europe.

NeuroScientific Biopharmaceuticals reported positive clinical responses in its StemSmart™ Special Access Program for fistulising Crohn’s disease and has initiated manufacturing technology transfer to support Phase 2 trials planned for late 2026.

Cynata Therapeutics has completed the 100-day primary evaluation period for its Phase 2 trial of CYP-001 in acute graft versus host disease, with results expected in June 2026. This milestone marks a critical step for the biotech’s lead cell therapy candidate in a condition with few effective treatments.

NeuroScientific Biopharmaceuticals reported a $1.7 million loss for the half-year ending December 2025, driven by ongoing R&D investments. The company progressed clinical treatments for Crohn’s disease and glaucoma, alongside key leadership appointments and strategic partnerships.

NeuroScientific Biopharmaceuticals has reported promising initial clinical responses from its StemSmart™ Special Access Program treating Fistulising Crohn’s Disease, while preparing for a pivotal Phase 2 trial in 2026.

Cynata Therapeutics has completed enrolment in major clinical trials for osteoarthritis and acute graft versus host disease, with pivotal results expected in the second quarter of 2026. The company also strengthened its patent portfolio and secured additional funding to extend its operational runway.

Cynata Therapeutics has successfully raised $1.2 million through an At-The-Market equity raise, issuing shares at a discount to support its ongoing clinical programs. This capital injection aims to bolster working capital as the company advances its proprietary stem cell therapies.

NeuroScientific Biopharmaceuticals reports encouraging clinical responses in fistulising Crohn’s disease patients treated under Australia’s Special Access Scheme, setting the stage for pivotal Phase 2 trials later this year.