Latest Clinical Development News

Cleo Diagnostics (ASX:COV) posted a 48% jump in annual loss to $5.9 million amid key progress in its ovarian cancer diagnostic test, including completion of a pivotal US trial and preparations for FDA 510(k) submission.

Percheron Therapeutics reduced its FY2026 loss to $4.79 million as it prepares to launch a pivotal phase II trial for its immuno-oncology drug HMBD-002, while managing a CEO transition and tightening cash reserves.

Entropy Neurodynamics has partnered with BioCina to establish GMP manufacturing for its intravenous psilocin formulation TRP-8803, a critical step toward late-stage clinical trials and commercialisation.

Radiopharm Theranostics is gearing up for a pivotal Phase 3 trial of its brain metastases imaging agent RAD101, following strong Phase 2b results and an upcoming FDA meeting to finalise trial design.

Dimerix has secured full sponsorship of the US Investigational New Drug application for its Phase 2-ready kidney drug DMX-652, setting the stage for a clinical trial targeting acute kidney injury in late 2026.

NeuroScientific Biopharmaceuticals (ASX:NSB) has locked in a key FDA Pre-IND meeting for late August, advancing its Phase 2 trial plans for StemSmart™ targeting refractory Crohn’s disease in the US and Australia.

Starpharma has successfully completed a $32 million entitlement offer, nearly fully subscribed, to fund its DEP® HER2-Lutetium Phase 1 trial and further develop its oncology pipeline.

Argent BioPharma's licensing partner Splash Beverage Group has launched the US veterinary development program for CannEpil®, targeting companion-animal oncology and chronic pain. Led by industry veteran Dr Hunter Land, the initiative follows a defined FDA regulatory pathway and could broaden CannEpil®’s commercial footprint beyond human neurology.

Neuren Pharmaceuticals saw a record Q2 with DAYBUE net sales hitting US$125 million, driven by strong uptake of the new STIX formulation. The company upgraded its 2026 royalty guidance following Acadia Pharmaceuticals’ sales boost and awaits key regulatory milestones in Europe and Japan.

Neurotech International has secured $4.5 million through a share placement to fund its pivotal Phase III clinical trial of NTI164 for Autism Spectrum Disorder, aiming to reach topline data readout.

Amplia Therapeutics has teamed up with Eli Lilly to test its FAK inhibitor narmafotinib alongside Lilly’s KRAS G12C inhibitor olomorasib in advanced non-small cell lung cancer, marking a strategic expansion beyond pancreatic and ovarian cancers.

Neurotech International has secured FDA clearance for its NTI164 Investigational New Drug application and obtained Notices of Allowance for two US patents, advancing its Phase 3 autism spectrum disorder program.