Latest Cell Therapy News

AdAlta and Shanghai Cell Therapy Group have approved the FDA briefing pack and manufacturing transfer plan for EW-001, bringing the mesothelioma CAR-T therapy closer to an Australian Phase 1 trial. The FDA meeting is scheduled for November, while two Chinese patients remain under follow-up, including a second complete responder.

Chimeric Therapeutics remains suspended from ASX trading after failing to lodge its FY2026 financial statements, with the company reporting an approximate $7.7 million net asset deficiency and unresolved creditor negotiations. Potential recapitalisation interest has emerged, but no binding funding or settlement agreement has been reached.

Cynata Therapeutics (ASX:CYP) has reported a $9.25 million loss, negative net assets and a material uncertainty over going concern after its two major clinical trials failed to demonstrate efficacy. The company has since cut its workforce to zero, shifted management to the board and secured a $600,000 R&D tax incentive loan while it considers the future of its Cymerus platform.

Mesoblast has secured FDA approval to add a new potency assay to commercial release and stability testing for Ryoncil, its approved cell therapy for paediatric graft-versus-host disease. The regulatory decision supports tighter monitoring as manufacturing processes evolve, but the company disclosed no direct financial impact or clinical outcome data.

AdAlta has secured a formal US FDA pre-IND meeting for EW-001, moving its mesothelioma CAR-T therapy into a critical regulatory review. The November meeting will test the company’s Australian manufacturing, remaining studies and proposed Phase 1 trial before the more expensive stages of development begin.

AdAlta says a 10-year, up to US$120 million agreement between manufacturing partner Oribiotech and an undisclosed commercial-stage biopharmaceutical company validates its choice of IRO automation for future cellular immunotherapies. The deal does not create direct revenue for AdAlta, and its lead asset EW-001 will continue with a separate manufacturing process.

Arovella Therapeutics has released the first clinical batch of its off-the-shelf cell therapy ALA-101 and activated its inaugural trial site at The Alfred, setting the stage for patient dosing later this month.

AdAlta’s partner SHcell has gained regulatory approval to provide the BZDS1901 CAR-T therapy to advanced mesothelioma patients in China’s Hainan Boao Lecheng special access zone, marking a key milestone in real-world data collection and treatment availability.

Vitrafy Life Sciences has secured its first US cell and gene therapy foothold by deploying its cryopreservation technology at Charter Medical's Innovation Hub, signalling a strategic expansion into a high-value biopharma segment.

NeuroScientific Biopharmaceuticals posted a $4.69 million loss for FY2026, driven by R&D ramp-up and clinical progress with its StemSmart™ platform, while halting independent development of its glaucoma drug EmtinB to pursue licensing deals.

Prescient Therapeutics launches a $7 million Share Purchase Plan at an 18.8% discount to fund advancement of its PTX-100 cancer therapy beyond a key 2026 Dose Optimisation Committee review.

AdAlta Limited (ASX:1AD) has progressed its ‘East to West’ cellular immunotherapy strategy by securing its first CAR-T asset, advancing Australian manufacturing and US FDA regulatory engagement, while raising A$5.3 million in FY2026 and reporting a net loss of $4.68 million.