Latest Regulatory Pathways News

LTR Pharma has initiated commercial distribution of its nasal spray SPONTAN through Australia's Symbion pharmacy network and is advancing ROXUS development for a US launch in early 2026, while expanding its pipeline with a new intranasal treatment for swallowing disorders.

EMVision Medical Devices has secured ethics approvals for two pivotal clinical studies and received a $400,000 milestone payment, marking significant progress toward commercialising its portable First Responder brain scanner.

Neurizon Therapeutics has formally responded to the FDA's clinical hold on its lead ALS drug NUZ-001, submitting new animal safety data. The company aims to join the HEALEY ALS Platform Trial by late 2025, pending regulatory approval.

Amplia Therapeutics has launched a $27.5 million capital raising to advance its lead drug Narmafotinib, a promising FAK inhibitor showing superior efficacy in pancreatic cancer trials. The funds will support ongoing and new clinical studies, positioning the company for pivotal regulatory milestones.

Amplia Therapeutics has successfully raised A$25 million through an institutional placement and launched a A$2.5 million Share Purchase Plan to fund pivotal clinical trials of its lead drug narmafotinib. The capital injection positions the company to advance key pancreatic and ovarian cancer studies into 2027.

Tetratherix Limited has marked a pivotal quarter with a $25 million ASX listing, an exclusive licensing agreement with Bio Optix for ophthalmic devices, and progress on FDA regulatory submissions for its prostate spacer product.

Adherium Limited has appointed seasoned medtech executive Dawn Bitz as CEO to spearhead the expansion of its Hailie® respiratory monitoring platform, with a strong focus on the US market.

InhaleRx Limited has secured key ethics approvals and initiated manufacturing for its inhaled drug candidates targeting breakthrough cancer pain and panic disorder, supported by a $38.5 million funding facility to accelerate development.

Microba Life Sciences reports strong Q4 FY25 growth driven by record microbiome test sales and clinician adoption in Australia and the UK, while advancing its therapeutics pipeline and targeting regional break-even in FY26.

Cleo Diagnostics reports steady progress in its ovarian cancer diagnostic test development, with clinical trial recruitment on track and strategic access to major biobanks enhancing its regulatory pathway.

Cobre Limited has initiated an Environmental Impact Assessment and reported strong assay results from its Ngami Copper Project, setting the stage for a maiden Mineral Resource Estimate by August 2025.

Dundee Precious Metals Inc. (DPM) has announced a recommended acquisition of Adriatic Metals Plc, valuing the company at approximately USD 1.322 billion. The deal offers Adriatic shareholders a mix of cash and shares, representing a significant premium and marking a major consolidation in the precious metals sector.