Latest Clinical Trials News

Acadia Pharmaceuticals has received a negative vote from the European Medicines Agency’s committee on its application to market trofinetide for Rett syndrome in the EU, prompting plans for a re-examination request.

Imricor Medical Systems has welcomed Oklahoma Heart Institute as the fourth U.S. site in its pivotal VISABL-AFL clinical trial, accelerating patient recruitment and the FDA approval pathway for its MRI-guided cardiac ablation technology.

Aroa Biosurgery reaffirms strong FY26 guidance, buoyed by favourable US Medicare reimbursement for Symphony and promising trauma study results for Myriad.

Biome Australia has secured ethics approval to commence a pivotal human clinical trial of its proprietary probiotic strain BMB18, aiming to validate its benefits on digestive, sleep, and mood health.

Actinogen Medical has raised approximately $17 million through a share placement and purchase plan to fund the completion of its pivotal XanaMIA Alzheimer’s trial following encouraging interim results.

PYC Therapeutics has launched a A$653 million capital raising to fund the clinical advancement of four RNA-based drug candidates targeting genetic diseases with significant unmet needs. The raise extends the company’s cash runway to 2030, supporting key clinical milestones and a transition to commercialisation.

PYC Therapeutics has launched a substantial $653 million equity raise to fund clinical trials for four promising drug candidates targeting genetic diseases. This capital injection aims to advance the company’s pipeline through critical human efficacy milestones.

Cyclopharm has reported a record $32.3 million in operating revenue for FY2025, led by explosive growth in its U.S. Technegas market following FDA approval. The company reaffirms its ambitious target of 250–300 U.S. installations by mid-2026 amid strong clinical momentum.

Neurotech International has secured ethics approval to launch its Beyond Harmony Phase 3 clinical trial of NTI164 for autism spectrum disorder, marking a key step toward regulatory submissions in Australia and the US.

Imagion Biosystems has submitted its Investigational New Drug application to the U.S. FDA for its MagSense® HER2 Imaging Agent, marking a pivotal step toward launching a Phase 2 clinical trial for breast cancer detection.

Argenica Therapeutics has won a crucial regulatory waiver from the European Medicines Agency, removing the need for paediatric trials for its stroke drug ARG-007 and clearing the way for faster adult market approval in Europe.

Small caps did the heavy lifting this week, led by two big discovery stories in resources. Funding raises and takeover moves kept attention on who can pay for the next step, not just promise it.