Latest Advanced Therapies News

IDT Australia reports a sharp turnaround in FY26 with a 66% reduction in net loss and an 85% improvement in EBITDA, underpinned by a strategic reset and targeted investments in manufacturing capabilities.

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.

EBR Systems has launched the WiSE Coupler in the US, a new accessory designed to improve the implantation of its wireless cardiac pacing electrode. The device has FDA clearance and was piloted in 10 procedures, marking another step in the company’s US commercial expansion.

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.

Cryosite Limited reported a robust half-year with revenue up 25% and net profit rising 36%, driven by strong demand in temperature-controlled logistics and a strategic warehouse acquisition that doubles its storage capacity.

IDT Australia reports a robust 20.3% increase in core revenue and a dramatic narrowing of EBITDA losses, signalling early success from its strategic realignment under new leadership.

IDT Australia Limited has reported a significant narrowing of its half-year loss to $1.3 million, driven by stable revenues and operational efficiencies. The pharmaceutical manufacturer highlights growth in key segments despite some timing setbacks.

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.

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.