Latest Advanced Therapies News

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.

Chimeric Therapeutics has progressed its CHM CDH17 and CHM CORE-NK clinical trials with promising safety and efficacy signals, while securing a key manufacturing partnership and appointing a renowned haematologist to its board. However, the company faces a pressing cash runway challenge.

Cynata Therapeutics is on track to deliver key clinical trial results in mid-2026 while maintaining a solid cash runway supported by an imminent R&D tax rebate and equity facility.

IDT Australia announces a strategic realignment focusing on profitability and operational efficiency, reporting strong revenue growth from its three core verticals and securing $3.4 million in new contracts for FY26.

Osteopore Limited has established OsteoRx, a new special purpose vehicle, with an initial AUD 0.5 million investment to accelerate breakthroughs in cellular regenerative medicine. This strategic move integrates a controlling stake in US-based RxCell Inc, expanding Osteopore’s footprint in the fast-growing stem cell market.

Mesoblast reports a strong FY2025 financial performance driven by the commercial launch of Ryoncil, the first FDA-approved mesenchymal stromal cell therapy for steroid-refractory acute graft-versus-host disease in children. The company is advancing multiple clinical programs targeting inflammatory diseases, heart failure, and chronic low back pain.

Cryosite Limited reported a 12% increase in revenue for FY25, driven by a 58% surge in its ultra-frozen and cryogenic segment, while deferring dividends to fund expansion plans.

IDT Australia Limited reported a strong 40.6% increase in revenue to $19.86 million for FY25, driven by growth in advanced therapies and contract disbursements. However, the company’s net loss widened to $8.06 million as it transitions from its ‘Rebuild Strategy’ to a new phase focused on sustainable profitability.

Vitrafy Life Sciences reported robust progress in Q4 FY2025, advancing its cryopreservation technology and commercial partnerships while preparing for a pivotal product launch in FY2026.

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.

Mesoblast reports positive FDA progress on accelerated approval for Revascor in ischemic heart failure and plans a pivotal trial to extend Ryoncil’s label to adults with graft versus host disease, while its US commercial launch outpaces expectations.

Alterity Therapeutics is set to present compelling Phase 2 clinical trial results for ATH434 at the 2025 International Multiple System Atrophy Congress, highlighting slowed disease progression and biomarker engagement in MSA patients.