Latest Regulatory Affairs News

Arovella Therapeutics has bolstered its financial position with a $20 million placement, fully funding the Phase 1 clinical trial of its lead CAR-iNKT therapy, ALA-101, targeting CD19-positive blood cancers. The company also established a Clinical Advisory Board and anticipates key regulatory and clinical milestones in 2025.

HeraMED reports a surge in its HeraCARE platform users and secures $4.1 million in new funding, underpinning its expansion in the US maternity care market and integration with major health systems.

Astron Corporation has made significant strides in developing its Donald Rare Earths and Mineral Sands Project, securing $14.5 million in funding and progressing towards a Final Investment Decision in 2025 amid key regulatory and operational milestones.

Optiscan Imaging Ltd reported a productive December quarter, marked by key product developments, strategic partnerships, and a stronger cash position, setting the stage for growth in medical and veterinary imaging markets.

TrivarX has solidified its regulatory strategy for the pivotal MEB-001 trial with the FDA and unveiled a new algorithm that expands its mental health screening reach beyond sleep clinics.

Alterity Therapeutics has reported positive Phase 2 results for ATH434, showing significant slowing of Multiple System Atrophy progression and a favorable safety profile. The trial demonstrated clinical benefits alongside reductions in brain iron accumulation, a key disease driver.

Black Dragon Gold's rezoning application for its flagship Salave Gold Project was rejected by local authorities, posing challenges for mining development. Meanwhile, the company secured a strategic placement raising AUD$712,000 to support ongoing operations.

Alterity Therapeutics has announced encouraging Phase 2 trial results for ATH434, showing significant slowing of disease progression in multiple system atrophy (MSA) patients and a strong safety profile. These findings mark a potential breakthrough in treating a disease with no approved therapies.

Argenica Therapeutics has received a positive safety review from its independent DSMB for the Phase 2 trial of ARG-007 in acute ischaemic stroke patients, with dosing now 86% complete and full recruitment expected by early Q2 2025.

Latitude66 has made significant strides in its flagship KSB Project in Finland, initiating a scoping study and reporting promising exploration results, while also completing the sale of its non-core Australian Sylvania Project.

Starpharma reports encouraging FDA feedback on its DEP® SN38 candidate for ovarian cancer and prepares for product launches in Saudi Arabia and UAE, supported by a solid $20.3 million cash position.

Neurotech International reports key clinical progress in paediatric neurological disorders, securing FDA orphan drug designation for its Rett Syndrome treatment and advancing pivotal trials for ASD and PANDAS/PANS.