Latest Regulatory Affairs News

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.

PYC Therapeutics reports substantial progress across all four of its drug development programs in Q4 2024, including key regulatory designations and clinical milestones that set the stage for pivotal trials in 2025.

Neurizon Therapeutics reports encouraging 8-month interim results for its ALS drug NUZ-001, secures Orphan Medicinal Product Designation in Europe, and raises $885,000 through a share placement, maintaining a robust $14 million cash position.

Algorae Pharmaceuticals reports robust progress in its drug development pipeline, highlighted by promising preclinical results for cardiovascular and dementia candidates and significant AI platform enhancements.

CurveBeam AI has reported a record quarter for HiRise™ device purchase orders, driven by a strategic expansion with Stryker in Australia and New Zealand. The company also advanced its FDA regulatory pathway for its BMD module, setting sights on mid-2025 submission.

Syntara Limited has reported encouraging interim Phase 2 trial results for its lead drug candidate SNT-5505 in myelofibrosis, alongside a successful A$15 million capital raise to advance multiple clinical programs.

Energy Resources of Australia (ERA) reports a robust cash position following a $766 million entitlement offer, advancing rehabilitation at its Ranger Project while seeking to extend its operational authority beyond January 2026.