Latest Cell Therapy News

Orthocell has swiftly converted regulatory approval into clinical use with the first Remplir™ surgery completed in a US Department of Defense hospital, marking a key step in its US commercial expansion.

Mesoblast has acquired exclusive rights to a patented chimeric antigen receptor platform designed to enhance the targeting and potency of its mesenchymal stromal cell therapies, aiming to expand treatment options for inflammatory and autoimmune diseases.

Telix Pharmaceuticals and Regeneron have entered a strategic collaboration to co-develop next-generation radiopharmaceutical therapies, with Telix receiving a $40 million upfront payment and potential milestones exceeding $2 billion.

Mesoblast Limited (ASX:MSB, Nasdaq:MESO) has received FDA Investigational New Drug clearance to initiate a pivotal clinical trial of its cell therapy Ryoncil in children with Duchenne Muscular Dystrophy, aiming to address inflammation-driven disease progression.

Mesoblast Limited (ASX:MSB, Nasdaq:MESO) reported net sales of US$30.3 million for its FDA-approved cellular therapy Ryoncil in the March quarter, bringing total revenue since launch close to US$100 million. Strong sales in February and March offset January’s seasonal dip.

AdAlta’s BZDS1901 CAR-T therapy shows remarkable tumour shrinkage and complete responses in advanced mesothelioma patients, doubling expected outcomes and paving the way for higher dosing and expanded trials.

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.

AdAlta’s subsidiary AdCella has completed its first Joint Development Committee meeting with Shanghai Cell Therapy Group, advancing the development of the CAR-T therapy BZDS1901 with potential timeline acceleration and reduced regulatory risks.

Arovella Therapeutics has secured TGA confirmation to advance its Phase 1 trial of ALA-101 in Australia via the efficient Clinical Trial Notification pathway, following FDA clearance in the US.

Imugene Limited has launched a $20 million capital raising through a $12 million institutional placement and an $8 million Share Purchase Plan, alongside a convertible notes amendment to support its clinical development pipeline.

Imugene Limited reports striking early results from its Phase 1b azer-cel trial, achieving a 100% overall response rate in chronic lymphocytic leukemia and 80% in marginal zone lymphoma, while broadening its study to include a BTK inhibitor combination.

Chimeric Therapeutics has secured a $1.785 million advance against its anticipated FY26 Research and Development Tax Incentive to bolster its clinical trial pipeline and working capital.