Latest Clinical Trials News

Recce Pharmaceuticals has locked in a non-dilutive A$30 million debt facility with Avenue Capital Group, extending its cash runway to support pivotal Phase 3 trials and commercialisation of its synthetic anti-infective R327G.

Clarity Pharmaceuticals has partnered with SpectronRx to manufacture and distribute its lead prostate cancer diagnostic, Cu-64 SAR-bisPSMA, at commercial scale across the US. This agreement sets the stage for a seamless launch pending FDA approval.

CSL has secured FDA approval for ANDEMBRY®, a pioneering treatment for hereditary angioedema, enabling an immediate US launch with promising clinical results. This milestone marks a significant advance in managing a rare but debilitating condition.

Nyrada’s Phase I clinical trial for its novel drug Xolatryp has cleared safety reviews through four cohorts and will now test higher doses and longer infusions in an expanded trial design.

Amplia Therapeutics has reported a rare pathological complete response in a patient from its ACCENT trial, highlighting promising potential for its drug narmafotinib in treating advanced pancreatic cancer.

EMVision Medical Devices has secured a $5 million non-dilutive government grant to accelerate global commercialisation of its innovative First Responder portable brain scanner, aimed at revolutionising pre-hospital stroke and brain injury care.

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.

Syntara Limited has unveiled encouraging interim Phase 2a data for SNT-5505, an add-on therapy targeting myelofibrosis patients with suboptimal response to ruxolitinib. The data highlight meaningful symptom relief and spleen volume reduction, positioning the drug as a potential game-changer in a challenging treatment landscape.

Clarity Pharmaceuticals’ novel PET imaging agent Cu-SAR-Bombesin demonstrated safety and effectiveness in detecting prostate cancer recurrence missed by standard scans in its Phase II SABRE trial. The agent identified lesions in about one-third of patients with negative or equivocal standard imaging.

Invion Limited launches a Loyalty Option entitlement offer aimed at raising up to $16 million to support its advancing cancer clinical trials, including a promising anogenital cancer study with Peter MacCallum Cancer Centre.

Dimerix has reached a key milestone by dosing 200 adult patients in its Phase 3 ACTION3 trial for FSGS, progressing steadily toward full recruitment expected in late 2025.

Syntara Limited reports encouraging interim Phase 2 data for its drug SNT-5505 combined with ruxolitinib, demonstrating significant symptom relief and spleen volume reduction in myelofibrosis patients. The company plans to engage the FDA soon to discuss pivotal trial design.