Latest Patient Enrolment News

Anteris Technologies has gained shareholder approval for an ASX waiver allowing flexible capital raising and updated its PARADIGM trial timeline, now set to begin patient enrolment in Q4 2025 after addressing FDA requests.

Race Oncology has secured Investigational New Drug approval from South Korea’s regulatory authority, enabling Phase 1 clinical trials of RC220 in combination with doxorubicin for solid tumour patients across four Korean sites.

Argenica Therapeutics has reported positive Phase 2 trial results for ARG-007 in acute ischemic stroke patients, confirming safety and revealing a promising efficacy signal in a high-risk subgroup with slow collateral blood flow.

Race Oncology has activated its first clinical trial site in Hong Kong for the Phase 1 study of RC220 combined with doxorubicin in advanced solid tumours, marking a significant step in accelerating patient enrolment and broadening clinical data.

Lumos Diagnostics, backed by BARDA, is set to begin a pivotal pediatric clinical study to extend the use of its rapid respiratory infection test, FebriDx, to children aged 2–12 in U.S. CLIA-waived settings, potentially unlocking a $1 billion market.

Recce Pharmaceuticals reported a 21% increase in net loss to $21.4 million for FY2025, driven by intensified R&D spending. The company secured key regulatory approvals for Phase 3 trials of its lead anti-infective gel and bolstered its financial position with significant capital raises and grants.

Cambium Bio reported a $3.84 million loss for FY25 but secured critical FDA approvals and ethics clearances to initiate Phase 3 trials of Elate Ocular®, supported by a $2.12 million capital raise.

Paradigm Biopharmaceuticals marked FY25 with the launch of its global Phase 3 trial for its osteoarthritis drug iPPS, backed by strong FDA protocol approval and a $41 million funding facility. The company also broadened its pipeline with the acquisition of Pentacoxib™, targeting early-stage OA.

EMVision Medical Devices is set to activate its sixth and final pivotal trial site at UCLA Health, advancing its emu™ brain scanner towards FDA submission. Meanwhile, the Continuous Innovation Study grows with the addition of Box Hill Hospital.

Actinogen Medical reported a $14.7 million net loss for FY25 while progressing its lead drug Xanamem through pivotal Alzheimer’s and depression trials, with interim results expected in January 2026. The company has secured funding through mid-2026 and is preparing for commercialization.

Vitasora Health has expanded its partnership with Tampa Family Health Centers to deliver chronic care and remote monitoring services to 7,000 Medicaid patients, unlocking over US$4 million in annual revenue. This marks a pioneering step for Florida’s largest Federally Qualified Health Center in adopting value-based care for underserved communities.

Anteris Technologies reported solid clinical progress with 130 patients implanted with its DurAVR heart valve and is gearing up for its pivotal PARADIGM trial with 79 qualified sites worldwide. The company also strengthened its leadership with two new board members amid ongoing FDA engagement.