Latest Cell Therapy News

Arovella Therapeutics has taken a significant step forward by submitting an IND application to the U.S. FDA for its lead CAR-iNKT cell therapy, ALA-101, targeting blood cancers. This milestone paves the way for a first-in-human Phase 1 trial in both Australia and the U.S.

Cynata Therapeutics has finalised patient enrolment in its pivotal Phase 2 trial of CYP-001 for acute graft versus host disease, setting the stage for critical data due mid-2026.

An independent meta-analysis presented at the ASH Annual Meeting reveals Mesoblast’s remestemcel-L achieves superior remission rates and safety outcomes compared to ruxolitinib in treating steroid-refractory acute graft-versus-host disease.

Imugene Limited has received positive feedback from the FDA, aligning key requirements to progress its azer-cel therapy into a pivotal clinical trial, underscoring its growing promise in blood cancer treatment.

Chimeric Therapeutics has won FDA Orphan Drug Designation for its CHM CDH17 CAR-T therapy targeting gastric cancer, advancing its clinical development with regulatory incentives and potential market exclusivity.

AdAlta Limited has received a $0.78 million Research and Development Tax Incentive refund for FY2025, using part of it to repay a Radium Capital loan and strengthening its cash position as it nears a key licensing milestone.

Imugene Limited and JW Therapeutics have launched a strategic collaboration to combine oncolytic virus and CAR-T cell therapies, aiming to tackle refractory solid tumors through a pioneering 'mark and kill' approach.

Mesoblast Limited forecasts a significant jump in quarterly revenue, driven by strong sales of its FDA-approved cell therapy Ryoncil. The company’s latest update highlights robust growth and ongoing expansion in inflammatory disease treatments.

Mesoblast has achieved a landmark FDA approval for RYONCIL, the first allogeneic mesenchymal stromal cell therapy, driving strong commercial momentum and advancing a robust pipeline targeting inflammatory diseases.

Chimeric Therapeutics has received a $4.5 million R&D tax incentive refund from the Australian Government, underscoring its ongoing investment in innovative cancer cell therapies.

Cynata Therapeutics has completed the final patient visit in its Phase 3 trial for CYP-004, targeting knee osteoarthritis, with results expected in mid-2026. This milestone advances hopes for a disease-modifying therapy in a market desperate for new options.

Chimeric Therapeutics reports promising interim results from its CHM CDH17 Phase 1/2 trial, with 75% disease control at 28 days and durable responses in gastrointestinal cancers.