Latest Cellular Therapies News

Mesoblast has treated 350 patients in its pivotal Phase 3 trial for rexlemestrocel-L, targeting chronic low back pain linked to degenerative disc disease, setting the stage for top-line results in mid-2027.

Mesoblast has completed treatment of 300 patients in its pivotal Phase 3 trial for rexlemestrocel-L, targeting chronic low back pain due to degenerative disc disease, with topline results expected mid-2027.

Mesoblast has received a Biologics License Application filing number from the FDA for rexlemestrocel-L, targeting life-threatening bleeding in end-stage heart failure patients with LVADs, advancing its regulatory journey with orphan drug and RMAT designations.

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 Limited has launched its 'East to West' cellular immunotherapy operations through a strategic collaboration with Shanghai Cell Therapy Group to co-develop BZDS1901, an innovative CAR-T therapy targeting mesothelioma and other solid cancers. The company also strengthened its balance sheet by raising $2.8 million via private placements and repaying key investment agreements.

AdAlta Limited has raised A$1.2 million through a strategic placement to advance its innovative PD1 armored MSLN CAR-T therapy for solid cancers, reinforcing its unique 'East to West' cellular immunotherapy approach.

Mesoblast has refinanced its senior debt with a new US$125 million, five-year credit facility that lowers borrowing costs and preserves key assets, positioning the company for strategic growth.

Prescient Therapeutics has secured European authorization to initiate a Phase 2a clinical trial of its novel cancer drug PTX-100 for relapsed/refractory Cutaneous T-cell Lymphoma, enabling trial site activation in Italy.

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.

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.

Mesoblast is set to meet the FDA in December to discuss compelling Phase 3 data showing its cell therapy rexlemestrocel-L may significantly reduce opioid use in chronic low back pain patients. This meeting could mark a pivotal step in addressing the US opioid crisis through innovative regenerative medicine.

AdAlta Limited has fully repaid its remaining NLSC investment in cash, ending its obligation to issue further shares and positioning itself for private capital raises to advance its CAR-T therapies.