Latest Clinical Trials News

Biotron Limited has met the first milestone in its Sedarex acquisition by securing pivotal regulatory feedback from the European Medicines Agency, charting a clearer path for its next-generation anaesthetic SedRx.

Vectus Biosystems has appointed Cardinal Health Regulatory Services as its US regulatory agent to manage FDA submissions for its lead fibrosis drug VB0004, marking a pivotal step towards clinical development in the US.

Island Pharmaceuticals has secured a critical collaboration with Texas Biomedical Research Institute to advance dose optimisation for its antiviral Galidesivir, targeting Marburg Virus Disease under the FDA Animal Rule. This second phase complements ongoing USAMRIID efforts and aims to de-risk pivotal study design with data from 32 non-human primates.

Immutep’s INSIGHT-003 trial shows promising overall survival in first-line non-squamous NSCLC, yet the Phase III TACTI-004 trial was discontinued following a futility analysis. Ongoing root cause investigations aim to clarify the divergent outcomes.

Cleo Diagnostics (ASX:COV) has entered the analytical validation phase for its ovarian cancer test, progressing toward an FDA 510(k) submission expected in early 2027.

INOVIQ Limited hit a roadblock in expanding clinical validation of its EXO-OC™ ovarian cancer test due to unsuitable biobank samples, yet improved its diagnostic algorithm and progressed its CAR-exosome therapeutic program, maintaining a solid cash position of A$9.35 million.

CLINUVEL Pharmaceuticals secures Canadian marketing approval for SCENESSE®, expanding access to the only approved systemic photoprotective treatment for erythropoietic protoporphyria (EPP).

Cryosite Limited reported an 18% rise in FY2026 revenue to $16.7 million, with EBITDA growing 27% amid completed and ongoing facility expansions. The company aims to convert new capacity into client growth in FY2027.

Dimerix will provide continued access to its investigational drug DMX-200 for eligible patients with focal segmental glomerular sclerosis after completing the pivotal ACTION3 Phase 3 trial, supporting ongoing treatment ahead of regulatory approval.

Cogstate Ltd smashed previous records with $89 million in net sales contracts for FY26, more than doubling the prior year. The company enters FY27 with a robust $118.5 million revenue backlog, signalling solid growth visibility.

Imugene has secured $11.12 million through a placement to advance its allogeneic CAR-T therapy azer-cel after early clinical data showed complete responses in BTKi-resistant lymphoma patients.

Alterity Therapeutics has secured official FDA confirmation that a single pivotal Phase 3 trial, backed by prior Phase 2 data, can support approval of ATH434 for Multiple System Atrophy. Trial initiation remains on track for late 2026.