Latest Clinical Development News

Radiopharm Theranostics' RAD 101 radiotracer demonstrates high sensitivity in detecting brain metastases using a novel PET-mpMRI approach, with a Phase 2b trial now recruiting in the US.

Neuren Pharmaceuticals has received a significant cash inflow of approximately US$50 million following the sale of a Priority Review Voucher linked to its Rett syndrome treatment. This milestone underscores the growing value of Neuren’s neurological drug portfolio and its partnership with Acadia Pharmaceuticals.

Nyrada has secured ethics approval to begin its first-in-human Phase Ia trial of NYR-BI03, a promising neuro- and cardioprotective drug candidate. Recruitment starts soon, with dosing expected by March and results due in Q3 2025.

Invex Therapeutics reports a significant reduction in net loss for H1 FY2025 alongside promising pre-clinical data for Exenatide in Alzheimer’s Disease models.

AdAlta Limited is accelerating its 'East to West' cellular immunotherapy strategy, aiming to bridge Asian innovation with Western clinical development and manufacturing to target solid cancers. The company plans to secure three assets by the end of 2025 and initiate clinical trials, positioning itself as a leader in this emerging market.

Neuren Pharmaceuticals has secured a pivotal FDA Type C Meeting to discuss primary efficacy endpoints for its Phase 3 trial of NNZ-2591 targeting Phelan-McDermid syndrome, advancing its rare disease drug development.

Actinogen Medical has published a peer-reviewed article confirming the efficacy of a 10 mg daily dose of Xanamem for treating neurological conditions, reinforcing its ongoing clinical trials in Alzheimer's and depression.

AdAlta has fast-tracked its cellular immunotherapy growth by signing two new term sheets for clinical-stage CAR-T products from Asia, pivoting to focus on in-licensing and clinical trials while winding down internal R&D on its antifibrotic drug AD-214.

Neurizon Therapeutics has been granted a pivotal US patent for its lead drug candidate NUZ-001, extending protection until 2039 and enhancing its commercial and clinical positioning in neurodegenerative disease treatment.

Biome Australia has partnered with the Food and Beverage Accelerator (FaBA) to jointly develop its promising BMB18 probiotic strain, leveraging $50 million in Australian government funding while retaining full IP ownership.

Noxopharm has successfully completed key in vitro safety tests for its SOF-SKN™ lupus drug, paving the way for the upcoming HERACLES Phase 1 clinical trial.

Alterity Therapeutics has raised over A$2 million through its U.S. ATM facility and expects nearly A$5.7 million in Australian tax rebates, fueling the advancement of its lead neurodegenerative drug candidate ATH434 following promising Phase 2 results.