Business

Neuren Pharmaceuticals (ASX:NEU) has reached a regulatory milestone with Health Canada approving its Clinical Trial Application for the Koala Phase 3 clinical trial of NNZ-2591, a drug candidate under development for Phelan-McDermid syndrome.

INOVIQ (ASX:IIQ) has reported preclinical evidence supporting the potential of its chimeric antigen receptor exosome technology as a next-generation cancer therapeutic.

Dimerix (ASX:DXB) has found itself at the centre of a significant global rare-disease transaction, following BioMarin Pharmaceutical’s US$4.8 billion acquisition of Amicus Therapeutics, the Australian company’s U.S. commercial licensing partner.

Clarity Pharmaceuticals (ASX:CU6) has taken a step toward regulatory approval of its diagnostic imaging agent, announcing it will commence a pivotal Phase 3 trial of Cu-64 SARTATE in patients with neuroendocrine tumours following positive guidance from the U.S. Food and Drug Administration.

Telix Pharmaceuticals (ASX:TLX) has delivered a significant advance in its global precision medicine strategy, announcing positive topline results from a pivotal Phase 3 registration study of TLX591-CDx (ILLUCCIX) in Chinese patients with prostate cancer.

Cleo Diagnostics (ASX:COV) has secured $5 million in capital to support its expansion into the United States and speed the development of a new mass screening test for ovarian cancer, in a raise that attracted strong backing from institutional and high-net-worth investors.

Actinogen Medical (ASX:ACW) has hit a significant milestone in its push to bring a new oral Alzheimer’s therapy to market, completing enrolment in its pivotal XanaMIA trial and confirming November 2026 for topline results.

OncoSil Medical (ASX:OSL) has marked a significant milestone in its manufacturing strategy, announcing the successful completion of the first 'hot' production test run at its new Sydney facility.

Island Pharmaceuticals (ASX:ILA) has taken a step forward in the development of its antiviral candidate galidesivir, securing a strategic partnership with the Texas Biomedical Research Institute, one of the world’s most advanced infectious disease centres and a critical player in high-containment pathogen research.

Australian medtech company Ferronova has raised a further $6 million to support the commercialisation of its image-guided cancer surgery technology.

A new antimalarial drug candidate developed through a long-running collaboration between Melbourne’s WEHI and MSD is showing promise in the fight against malaria, particularly as resistance to existing treatments continues to spread.

Radiopharm Theranostics (ASX:RAD) has announced encouraging interim results from its U.S.-based Phase 2b clinical imaging trial of RAD 101, reporting that 92 per cent of evaluable patients achieved concordance between RAD 101 PET imaging and MRI, the study’s primary endpoint.