Latest Advanced Therapies News

BTC Health’s investee, BTC Cardio, has landed exclusive Australian distribution rights for Jafron Biomedical’s hemoperfusion cartridges, aiming for a 2026 market debut pending regulatory approval.

A small-cap healthcare rally had a clear centre: distribution deals, US regulatory steps, and big cheques. Osteopore, Echo IQ and Anteris led the week, while a handful of names slipped despite solid operational updates.

Mesoblast has received encouraging feedback from the FDA on its cell therapy rexlemestrocel-L, showing meaningful pain relief and potential opioid use reduction in chronic low back pain patients. The company’s ongoing Phase 3 trial aims to confirm these benefits and advance regulatory approval.

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.