Latest Clinical Data News

Mesoblast has secured FDA agreement on key requirements for its Biologics License Application for Revascor, targeting ischemic heart failure patients with reduced ejection fraction. The company aims for accelerated approval by year-end 2025.

Neuren Pharmaceuticals has been granted a US patent for NNZ-2591 to treat Pitt Hopkins syndrome, bolstered by promising Phase 2 clinical trial results and FDA orphan drug status.

Paradigm Biopharmaceuticals has acquired Proteobioactives, securing global rights to an oral combination therapy targeting early-stage osteoarthritis in humans and animals, complementing its injectable PPS phase 3 program.

BlinkLab Limited has responded to an ASX query regarding recent unusual trading activity, confirming no undisclosed material information exists and highlighting pending ADHD diagnostic results expected later this year.

Amplia Therapeutics has secured US ethics approval to launch a Phase 2 trial combining its drug narmafotinib with FOLFIRINOX chemotherapy for advanced pancreatic cancer, marking a key step in its clinical development.

Optiscan Imaging Ltd has entered a five-year exclusive collaboration with Long Grove Pharmaceuticals to jointly develop new clinical applications for the fluorescein drug AK-FLOUR®, supporting US clinical trials and FDA regulatory submissions for Optiscan’s InVue® surgical device.

Argenica Therapeutics has won up to $1.5 million in non-dilutive government funding to support its late-stage clinical trial of ARG-007, a promising treatment for acute ischaemic stroke.

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.