Latest Regulatory Submissions News

Avecho Biotechnology is on the cusp of completing patient dosing in its pivotal Phase III CBD insomnia trial, backed by a recent $2.5 million capital raise and patent allowances in the US and Europe.

CurveBeam AI reported steady progress in Q2 FY26 with five new device purchase orders, a $4 million milestone payment pending receipt, and key regulatory submissions underway in the US and China.

Torque Metals is advancing its Paris Gold Camp project in Western Australia, moving from exploration to development readiness with a 250,000-ounce gold resource and an aggressive drilling program.

BPH Energy’s December quarter report reveals significant progress in its investee projects amid ongoing legal challenges and strategic capital management. The company balances judicial reviews, regulatory milestones, and funding plans across energy and medical technology sectors.

Genesis Resources progresses environmental approvals for its North Macedonian Plavica project while Australian drilling at Alice Springs and Arltunga yields underwhelming copper and gold assays.

LTR Pharma has marked a key milestone with over 1,000 SPONTAN prescriptions under Australia’s Special Access Scheme and is advancing clinical trials and US market preparations for its erectile dysfunction treatments.

Tetratherix Limited (ASX, TTX) reports significant progress in clinical trials, strategic partnerships, and manufacturing capacity, positioning itself for near-term commercialisation and sustained innovation.

EMVision Medical Devices reports strong progress in its emu™ Brain Scanner clinical trials, expanding recruitment across seven leading stroke hospitals and introducing new software features to enhance scan quality.

Echo IQ has completed clinical validation of its EchoSolv HF heart failure detection software with the Mayo Clinic Platform, achieving outstanding accuracy. The company has now formally submitted its FDA 510(k) clearance application, positioning itself for significant commercial expansion in the US healthcare market.

PYC Therapeutics has reported significant progress across its four RNA therapeutic programs targeting rare genetic diseases, supported by a strong cash position of $121 million at the end of 2025. Key clinical milestones and regulatory plans set the stage for upcoming trial readouts and potential market entry.

Viking Mines has secured a comprehensive historical dataset for its Linka tungsten project in Nevada, significantly cutting exploration time and costs. This strategic acquisition lays the groundwork for rapid 3D geological modelling and targeted drilling.

LTR Pharma has initiated dosing in its Phase II clinical trial for SPONTAN, a rapid-acting intranasal spray targeting erectile dysfunction, marking a key step toward FDA approval and commercial expansion.