Latest Clinical Trials News

Noxopharm Limited's CEO and Managing Director Dr Gisela Mautner has resigned after four years with the company, including leading a key strategic pivot. The biotech firm plans to announce her successor shortly.

Entropy Neurodynamics has dosed its third patient with TRP-8803 in a Binge Eating Disorder trial, achieving a full and controlled psychedelic response that underscores the drug’s potential for precise therapeutic delivery.

Clarity Pharmaceuticals has secured a major manufacturing deal with Nucleus RadioPharma to produce its next-generation prostate cancer imaging agent, 64Cu-SAR-bisPSMA, ramping up supply ahead of anticipated US market entry.

EMVision Medical Devices has ramped up recruitment in its pivotal FDA trial across eight hospitals and is nearing results from multiple pre-hospital studies, all while bolstering its cash position with a $3.8 million R&D tax refund and $6.6 million in grant funding.

Telix Pharmaceuticals has announced FDA acceptance of its resubmitted NDA for TLX101-Px (Pixclara®), a PET imaging agent for glioma, setting a PDUFA goal date of September 11, 2026. The agent addresses a significant unmet need in distinguishing recurrent glioma from treatment effects.

EBR Systems has reported a significant increase in commercial implantations of its WiSE System in Q1 2026, more than doubling case volumes from the previous quarter and projecting preliminary revenue between US$2.25 million and US$2.36 million.

Mesoblast Limited (ASX:MSB, Nasdaq:MESO) has received FDA Investigational New Drug clearance to initiate a pivotal clinical trial of its cell therapy Ryoncil in children with Duchenne Muscular Dystrophy, aiming to address inflammation-driven disease progression.

Neuren Pharmaceuticals’ partner Acadia Pharmaceuticals has broadened availability of DAYBUE STIX, a new FDA-approved powder formulation of trofinetide for Rett syndrome, in the US. Early caregiver feedback and expert consensus highlight its potential role in personalised patient care.

Radiopharm Theranostics has received a positive recommendation to escalate the dose of its 177Lu-RAD202 radiotherapeutic in a Phase 1 trial targeting HER2-positive advanced solid tumors, maintaining its timeline to complete dose escalation by year-end 2026.

Imricor Medical Systems has submitted its NorthStar Mapping System for FDA pediatric label expansion, aiming to accelerate adoption in over 250 US children’s hospitals and broaden its commercial footprint.

Cogstate Ltd (ASX:CGS) has announced robust sales contract execution for the quarter ended 31 March 2026, with $25.4 million in new contracts and a growing revenue backlog supporting its clinical trial services business.

Archer Materials has progressed its Biochip program by completing the alpha prototype and Stage 1 project with IMEC, now advancing to develop a beta prototype suitable for external use and clinical validation.