Latest Regulatory Updates News

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.

Imugene Limited has received positive feedback from the FDA, aligning key requirements to progress its azer-cel therapy into a pivotal clinical trial, underscoring its growing promise in blood cancer treatment.

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.

InvestSMART Funds Management has updated the Distribution Reinvestment Plan rules for its Intelligent Investor Active ETFs, making DRP participation automatic for new investors from January 2026 unless they opt out.

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.

Aroa Biosurgery reported a 14% rise in product sales to NZ$44.6 million for the half-year ended September 2025, driven by strong growth in its Myriad portfolio. The company also posted a normalised EBITDA profit and reaffirmed its FY26 revenue and profit guidance.

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.

The Foreign Investment Review Board has extended its deadline for approving Mayne Pharma's acquisition by Cosette Pharmaceuticals, maintaining the current transaction timetable for now.