Latest Regulatory Pathways News

Alterity Therapeutics reported a reduced net loss of A$12.15 million for FY2025, buoyed by positive Phase 2 clinical trial results for its lead drug ATH434 in Multiple System Atrophy and a successful A$40 million capital raising.

Cynata Therapeutics reported a $9.39 million net loss for FY2025, slightly improved from the prior year, while progressing multiple clinical trials with key results expected in 2026. The company maintains a solid cash position and funding runway through mid-2026, supported by recent capital raises and an equity subscription agreement.

Syntara Limited reported a significantly reduced loss for FY2025, driven by clinical progress and capital raises, while advancing its lead drug amsulostat with FDA Fast Track designation. The company also navigates ongoing payment disputes following the sale of its mannitol respiratory business.

Percheron Therapeutics posted a 25% increase in net loss for FY2025 amid termination of its Duchenne Muscular Dystrophy programs. The company pivots strategically to oncology with the in-licensing of HMBD-002, a monoclonal antibody targeting VISTA, aiming to initiate Phase II trials in 2026.

EMVision Medical Devices reported a sharp increase in FY25 losses alongside a 51% revenue drop, yet marked significant progress in clinical trials for its innovative brain scanners and secured $8 million in government grants to fuel commercialisation.

Cleo Diagnostics reported a $4 million loss for FY2025 while making significant strides toward FDA approval of its novel ovarian cancer blood test. The company is progressing clinical trials and scaling manufacturing in preparation for market entry.

Amplia Therapeutics has successfully raised A$2.65 million through its Share Purchase Plan, exceeding expectations and bolstering funding for pivotal clinical trials of its lead drug narmafotinib.

Holista Colltech has inked a binding supply and development agreement with US-based Regenerex Pharma to exclusively supply proprietary ovine collagen for advanced wound care products, targeting the lucrative US market initially with plans for global expansion.

Meteoric Resources confirms its Caldeira Rare Earth Project in Brazil remains on track after a disputed environmental council vote was declared invalid. Strong local government support and regulatory assurances underpin confidence in project timelines.

LTR Pharma’s SPONTAN nasal spray has achieved unanimous patient satisfaction in treating erectile dysfunction after prostate surgery, signaling a promising shift in therapy preferences.

Dalrymple Bay Infrastructure Limited has announced a quarterly dividend of 5.875 cents per stapled security, combining a partially franked dividend and a partial loan note repayment, payable in September 2025.

Viridis Mining and Minerals has significantly expanded its Colossus Rare Earth Elements project in Brazil, securing an additional 2,503.6 hectares adjacent to its existing licenses. This move, backed by robust government support and strategic partnerships, enhances the project's scale and de-risks its pathway to production.