Latest Regulatory Pathways News

Dimerix’s blinded review of its pivotal ACTION3 Phase 3 trial confirms over 90% statistical power to detect DMX-200’s effect on proteinuria, reinforcing the study’s design and regulatory pathway.

Orthocell’s latest Remplir™ Real World Evidence study reveals an 89.7% treatment success rate across 78 nerve repair procedures, reinforcing its clinical strength and fueling US and European market growth plans.

Algorae Pharmaceuticals has struck an exclusive commercial and licensing agreement with global pharma Zydus Lifesciences to bring 10 injectable, oral, and specialty medicines to Australia and New Zealand, pending regulatory approvals.

NH3 Clean Energy has marked strong progress in its WAH2 clean ammonia project by appointing Linde Engineering for FEED and securing a 15-year water supply agreement, setting the stage for a final investment decision by year-end.

Vitrafy Life Sciences completed Phase II of its U.S. Military platelet cryopreservation study with strong results for a simplified no-wash process, accelerating commercial interest and progressing FDA device registration despite manufacturing delays.

EVE Health Group has appointed Ben Rohr as CEO, shifting Damian Wood to focus on regulatory and clinical affairs, aiming to sharpen commercial execution amid ongoing product rollouts.

Brazilian Critical Minerals (ASX: BCM) has boosted the indicated mineral resource at its Ema rare earth project by 58%, now totalling 1.07 billion tonnes at 732 ppm TREO. This positions Ema as one of the world’s largest ionic clay rare earth deposits and the only ISR-ready project in the western world.

AdAlta, Oribiotech, and Cell Therapies have inked a Memorandum of Understanding to deploy Oribiotech’s IRO automated cell therapy manufacturing platform in Australia and Asia Pacific, aiming to slash costs and boost production speed for CAR-T therapies.

Patrys has raised A$3.2 million through a share placement to fund its injectable quetiapine program’s Phase 1A clinical trial and FDA pre-IND preparations.

Orthocell’s Q1 FY26 revenue hits $3.2 million, buoyed by growing US sales of its Remplir nerve repair device and a robust $48 million cash position supporting global expansion.

Radiopharm Theranostics has reported encouraging initial results from the Phase 1 HEAT trial of its novel HER2-targeted radiopharmaceutical, 177Lu-RAD202, highlighting tumor uptake and a clean safety profile at the lowest dose with dose escalation approved.

Memphasys Limited has marked a milestone quarter with revenue surpassing A$100,000, driven by repeat orders and multi-year contracts, signalling its transition to a commercially focused biotech business.