Latest Cell Therapy News

Imugene’s off-the-shelf CAR T therapy azer-cel has won FDA Fast Track Designation for relapsed or refractory CLL/SLL and MZL, backed by compelling Phase 1b response rates.

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.

Chimeric Therapeutics reports encouraging Phase 1/2 data for its CHM CDH17 CAR-T therapy in advanced gastrointestinal cancers, with 82% of evaluable patients achieving stable disease and durable responses lasting over a year.

Imugene has dosed the first patient in a new cohort combining its azer-cel CAR T therapy with BTK inhibitors, targeting patients with B-cell malignancies who failed prior BTKi treatment. This move broadens the trial’s scope and tackles a significant unmet need in blood cancer therapy.

AdAlta has engaged specialist advisors to streamline US FDA regulatory processes for its CAR-T therapy BZDS1901, which has shown rare complete tumour clearance in advanced mesothelioma patients.

Imugene Limited’s allogeneic CAR T therapy, azer-cel, delivered an 81% overall response rate in a Phase 1b trial cohort of CAR T-naïve patients with various CD19 B-cell malignancies, with updated data due at ASCO 2026.

Arovella Therapeutics has named Dr Nicole Van Der Weerden as acting CEO following Dr Michael Baker’s departure, positioning her to steer the company through the critical phase I trial of its CAR-iNKT therapy ALA-101.

Arovella Therapeutics undergoes a major board overhaul and CEO resignation following a shareholder push, as the company embarks on a strategic review of its cell therapy platform.

AdAlta has secured A$2.5 million in a strategic placement to push its lead CAR-T therapy BZDS1901 through critical US FDA regulatory steps and establish Australian manufacturing, building on promising clinical responses in advanced mesothelioma.

Cynata Therapeutics has secured A$1.5 million through an institutional placement priced at a 22.5% discount, aiming to extend its cash runway ahead of pivotal Phase 3 and Phase 2 trial results expected in May and June 2026.

Mesoblast Limited posted US$30.3 million in net revenues for Ryoncil® in Q3 2026, hitting key clinical milestones and securing new technology licenses that could boost its next-generation cell therapies.

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.