Latest Clinical Development News

Tryptamine Therapeutics reported a $5.33 million loss for FY25 while progressing key clinical trials of its psychedelic therapies and strengthening its leadership team. The company secured $6 million in funding and launched a world-first trial targeting Binge Eating Disorder.

PYC Therapeutics has reported promising safety data from the initial phase of its clinical trial for PYC-003, an RNA therapy targeting the root cause of Polycystic Kidney Disease. The findings, presented at the ANZSN conference, highlight the drug’s tolerability in healthy volunteers, paving the way for further clinical development.

Mesoblast Limited marked a transformative year with FDA approval and commercial launch of Ryoncil, its first mesenchymal stromal cell therapy, driving a 191% jump in cell therapy revenues. The company is now poised to expand its footprint in inflammatory diseases with multiple clinical trials and label extensions underway.

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.

Mesoblast Limited has reported its FY2025 results, highlighting the FDA approval and US commercial launch of Ryoncil, its first mesenchymal stromal cell therapy, alongside a $102.1 million net loss and $161.6 million in cash reserves.

Noxopharm Limited reported a 36.5% increase in its annual loss to $4.88 million as it progressed preparations for its SOF-SKN™ clinical trial and secured $2.6 million through convertible notes. The biotech continues to invest heavily in its inflammation and oncology drug pipeline while managing liquidity and strategic partnerships.

Cynata Therapeutics reported a $9.39 million net loss for FY2025, slightly improved from the prior year, while progressing multiple clinical trials with key results expected in 2026. The company maintains a solid cash position and funding runway through mid-2026, supported by recent capital raises and an equity subscription agreement.

NeuroScientific Biopharmaceuticals reported a $1.85 million loss for FY25, driven by reduced R&D incentives and increased development costs following its acquisition of StemSmart™ technology. The company is advancing clinical programs, including a Special Access Scheme for Crohn’s disease.

Algorae Pharmaceuticals reported a 62% reduction in net loss for FY2025, driven by R&D tax credits and cost efficiencies, while making significant strides in its AI drug discovery platform and therapeutic candidates.

Argenica Therapeutics reported a 34% revenue increase driven by R&D incentives but saw losses widen by 31% due to intensified clinical trial activity. The company is progressing its ARG-007 Phase 2 stroke trial and engaging with the FDA to lift a clinical hold.

Imugene Limited has successfully closed its Share Purchase Plan, raising $2.42 million following a $22.5 million institutional placement, reinforcing its capital position for ongoing immuno-oncology development.

Syntara Limited reported a significantly reduced loss for FY2025, driven by clinical progress and capital raises, while advancing its lead drug amsulostat with FDA Fast Track designation. The company also navigates ongoing payment disputes following the sale of its mannitol respiratory business.