Latest Clinical Data News

Race Oncology has successfully dosed the first patient with its RC220 and doxorubicin combination in a Phase 1 trial for advanced solid tumours, reporting no dose-limiting side effects. This milestone marks a key step in evaluating the safety and potential cardioprotective benefits of the novel therapy.

4DMedical has renewed and expanded its contract with Stanford University’s 3DQ Lab to include its innovative CT – VQ™ imaging technology ahead of FDA clearance, marking a significant step in its U.S. market expansion.

Bubs Australia has submitted critical clinical trial data to the US FDA, marking a pivotal step toward permanent approval for its infant formulas in the US market.

Island Pharmaceuticals has reported encouraging Phase 2a/b trial results for ISLA-101, demonstrating meaningful reductions in dengue viral load and symptoms in humans. The findings support further clinical development of this antiviral candidate.

Opyl Limited has secured strategic collaborations with two leading contract research organisations, integrating its AI-driven TrialKey platform into cardiovascular, oncology, and rare disease clinical trials to enhance trial design and accelerate commercial growth.

Radiopharm Theranostics has secured FDA Fast Track designation for RAD101, a novel imaging agent aimed at improving diagnosis of recurrent brain metastases. The move could speed development and regulatory review as the company advances its Phase 2 clinical trial.

Syntara Limited’s lead drug candidate SNT-5505 has secured FDA Fast Track designation, expediting its development for treating myelofibrosis, a rare and serious blood cancer with limited therapies.

Argenica Therapeutics faces a clinical hold from the US FDA on its stroke drug trial application, though its Australian Phase 2 study remains unaffected and on track.

Optiscan Imaging Ltd has launched InSpecta™, a cutting-edge microscopic imaging device tailored for veterinary medicine, marking its strategic entry into a booming $12 billion US market. The device promises to revolutionize diagnostics and treatment for companion animals with real-time, non-invasive imaging.

PainChek has advanced its US regulatory approval process with a positive FDA meeting, setting the stage for a potential market debut of its pain assessment app in late 2025.

Chimeric Therapeutics has secured FDA Fast Track designation for its CHM CDH17 CAR-T therapy targeting gastroenteropancreatic neuroendocrine tumours, accelerating its path toward regulatory approval and patient access.

EMVision Medical Devices has activated two additional key sites in its pivotal trial for the emu™ bedside brain scanner, advancing its path toward FDA clearance. These new sites join a growing network of leading stroke centres across the US and Australia.