Latest Cellular Therapies News

Mesoblast Limited is set to release its full-year financial results and operational highlights for 2025, spotlighting its FDA-approved cell therapy and expanding global partnerships.

Mesoblast has secured FDA agreement on key requirements for its Biologics License Application for Revascor, targeting ischemic heart failure patients with reduced ejection fraction. The company aims for accelerated approval by year-end 2025.

AdAlta Limited has announced a pro rata renounceable rights offer to raise approximately $1.29 million, aiming to fund its strategic pivot towards licensing CAR-T cell therapies through its subsidiary AdCella. The offer includes new shares and options, underpinned by key insiders and an underwriting agreement.

Vitrafy Life Sciences reported strong Q3 FY2025 progress, including a successful US Army blood platelet study, a $4.8 million government grant, and strategic US market expansion.

Imugene’s Phase 1b trial of azer-cel, an off-the-shelf CD19 CAR T therapy, reports a 57% complete response rate in heavily pretreated diffuse large B-cell lymphoma patients, signaling a promising new option in a challenging cancer landscape.

Mesoblast Limited is set to launch Ryoncil®, the first FDA-approved MSC therapy for pediatric steroid-refractory acute graft-versus-host disease, backed by a recent $160 million financing that strengthens its commercial and clinical development efforts.

Osteopore Limited reports a robust 27% year-over-year revenue increase despite operational headwinds, underpinned by new collaborations in stem cell therapies and expanded market access in Brazil and Singapore.

Mesoblast has secured FDA approval for Ryoncil®, the first mesenchymal stromal cell therapy for steroid-refractory acute graft versus host disease in children, while raising A$260 million to accelerate clinical trials and commercial rollout.

AdAlta Limited has bolstered its leadership team and progressed its 'East to West' cellular therapy strategy alongside its lead drug candidate AD-214, despite a tightening cash position. The company’s recent non-binding term sheet and new clinical data signal promising momentum in its biotech pipeline.

Imugene Limited reports durable patient responses in multiple cancer immunotherapy trials and strengthens its financial position with a $46 million convertible note deal and a substantial R&D tax refund.

Orthocell Limited has reported a third consecutive quarter of record revenue, driven by strong sales growth and strategic market expansions, including a key US FDA submission for its nerve repair product Remplir™.