Latest Cell Therapy News

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.

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.

Imugene Limited reports a narrower half-year loss as it advances its promising azer-cel CAR T therapy with strong clinical results and FDA backing, supported by a $25 million capital raise.

Orthocell Limited has reported a record half-year revenue of $6.2 million, driven by accelerating sales of its regenerative medicine products and expanding global footprint. The company’s US commercial launch of Remplir™ is gaining momentum alongside new market entries in Canada, Hong Kong, and Europe.