Latest Clinical Trials News

Syntara Limited has initiated dosing in its Phase 1c SATELLITE trial for a novel topical treatment targeting keloid scars, marking a significant step in addressing a $3.5 billion global market. The study, led by Professor Fiona Wood, will evaluate safety and early efficacy over three months.

Imagion Biosystems has received encouraging feedback from the FDA on its MagSense HER2 breast cancer imaging program, clearing the path for a Phase 2 clinical trial and fast-tracking manufacturing.

Prescient Therapeutics has extended its Share Purchase Plan closing date to 22 July 2025, aiming to raise up to A$7 million to advance its targeted cancer therapy PTX-100 through Phase 2 clinical trials.

Alterity Therapeutics has responded to an ASX inquiry about its recent share price and volume spike, confirming no undisclosed information but highlighting imminent clinical data releases and investor roadshows as possible drivers.

Nyrada has initiated the last cohort of its Phase I trial for Xolatryp, following a clean safety review of the highest dose tested so far. This step sets the stage for critical data that could shape the drug’s next development phase.

Imugene Limited reports promising Phase 1b trial results for azer-cel, an off-the-shelf CAR T therapy, showing a 75% overall response rate in relapsed diffuse large B-cell lymphoma patients. The company plans to engage the FDA later this year to discuss pivotal trial design.

Cambium Bio has secured FDA clearance to begin Phase 3 dosing of Elate Ocular, a promising treatment for moderate to severe dry eye disease, pending additional financing.

Imagion Biosystems has received encouraging feedback from the FDA on its planned Phase 2 HER2 breast cancer clinical trial, paving the way for its Investigational New Drug application submission later this year.

Neurizon Therapeutics has received positive feedback from the FDA on its plan to resolve the clinical hold on its ALS drug candidate NUZ-001, with key preclinical studies completed ahead of schedule. The company aims to resume clinical trials in late 2025.

Imricor Medical Systems has secured key European regulatory approvals for its second-generation NorthStar system and initiated its commercial launch, while US FDA submissions progress amid some delays.

Race Oncology has secured key ethics approvals to launch its Phase 1 RC220 trial at two major Hong Kong hospitals, marking a strategic expansion beyond Australia to accelerate patient recruitment and explore cardioprotective benefits.

Anatara Lifesciences has strengthened its intellectual property portfolio with a Japanese patent for its GaRP gastrointestinal health product, while progressing pre-clinical studies in its Anti-Obesity Project. The company also confirmed registration of its R&D Tax Incentive application for 2024-2025.