Latest Regulatory Updates News

A single diagnostics update sparked a breakout week, while a handful of biotech names sold off hard despite busy newsflow. Capital raisings, takeover steps and US market pushes kept healthcare in motion heading into mid-February milestones.

BCAL Diagnostics has launched its Avantect blood tests for pancreatic and ovarian cancer with encouraging early uptake and is advancing its BREASTESTplus breast cancer test towards broader clinical use.

Cann Group Limited has reported its first-ever free cash flow positive quarter, following a significant debt restructuring and a $9 million capital raise. Despite a softer quarterly revenue, the company is advancing new product launches and export partnerships, positioning itself for growth.

Electro Optic Systems (EOS) reports a record $459 million contract backlog, major new defence contracts including a $120 million laser weapon deal, and a strategic acquisition to boost counter-drone capabilities.

AdAlta Limited has aligned its AdCella manufacturing strategy with new US FDA guidelines, made a significant milestone payment to Shanghai Cell Therapy Group, and secured an additional R&D tax rebate, marking key progress in its cellular immunotherapy pipeline.

MRG Metals has completed its acquisition of the Garies Rare Earth Project, adding a high-grade, magnet-rich rare earth asset in South Africa to its portfolio. This move significantly boosts the company’s exposure to critical minerals essential for emerging technologies.

Neurizon Therapeutics has progressed its ALS treatment NUZ-001 into critical clinical trial phases, even as the FDA declines its Fast Track Designation request pending more data.

Aumake Limited has obtained a Hong Kong pharmaceutical wholesale licence, enabling it to launch up to five online over-the-counter medicine stores targeting Chinese consumers. This strategic move positions the company to tap into China’s rapidly expanding OTC market.

Vitasora Health has secured AU$3.56 million from a cornerstone investor, issuing over 118 million shares, while confirming compliance with key regulatory disclosure obligations.

Viridis Mining and Minerals Limited has addressed ASX concerns following unusual trading linked to a Brazilian environmental recommendation on its Colossus Project. The company remains confident in securing the project's Preliminary License despite the non-binding recommendation.

Reef Casino Trust’s takeover bid by Iris Cairns Property faces a regulatory hurdle as Queensland’s Office of Liquor and Gaming Regulation delays suitability investigations, pushing the offer period beyond March 2026.

Island Pharmaceuticals has secured FDA confirmation that its antiviral Galidesivir can proceed under the Animal Rule pathway for Marburg virus, qualifying for a lucrative Priority Review Voucher. This regulatory milestone accelerates the drug’s path to approval and potential government stockpile inclusion.