Latest Regulatory Milestones News

Medallion Metals has successfully completed the public comment phase under the EPBC Act for its Ravensthorpe Gold Project, advancing a critical regulatory milestone with no objections received. The company aims to submit final documentation in October and expects a decision before year-end, paving the way for its sulphide development strategy.

Race Oncology has secured Investigational New Drug approval from South Korea’s regulatory authority, enabling Phase 1 clinical trials of RC220 in combination with doxorubicin for solid tumour patients across four Korean sites.

Vonex Limited shareholders have overwhelmingly approved Maxo Telecommunications’ acquisition scheme, setting the stage for a court decision that could delist Vonex from the ASX.

Arovella Therapeutics has received a $3.21 million R&D tax incentive refund, bolstering its financial position as it prepares to initiate first-in-human trials for its lead cell therapy, ALA-101.

INOVIQ Limited has demonstrated that its CAR-NK-exosome therapy kills over 90% of triple-negative breast cancer cells within 10 hours in laboratory tests, validating its potential as a next-generation cancer treatment.

Echo IQ has completed its presentation to the CPT Editorial Panel for a Category III CPT code for EchoSolv AS, with a decision expected from the American Medical Association in the coming weeks. Meanwhile, the company is advancing US deployments and FDA clearance efforts.

Island Pharmaceuticals has won a crucial FDA Type C meeting to discuss fast-tracking its antiviral Galidesivir for Marburg virus treatment, with written feedback expected by November.

OncoSil Medical’s PANCOSIL Phase 1-2 study reveals promising safety and feasibility for a novel CT-guided pancreatic cancer therapy, with survival outcomes exceeding historical benchmarks.

Memphasys has upgraded its contract with ITL to A$390,000 and expanded its territory to include Turkey, marking its first contracted revenues in the EU ahead of expected CE Mark approval.

Epsilon Healthcare’s manufacturing arm has secured updated GMP certificates covering domestic and EU/UK markets, reinforcing its quality credentials and paving the way for expanded international contract manufacturing.

EMVision Medical Devices has raised $12 million through a placement backed by institutional investors, including strategic partner Keysight Technologies, and launched a Share Purchase Plan to raise up to $2 million from existing shareholders. The capital will support key clinical and regulatory milestones for its neurodiagnostic devices over the next two years.

Mad Paws Holdings has secured Foreign Investment Review Board approval for Rover Group’s full acquisition scheme, with the board unanimously recommending shareholder support.