Latest Regulatory Approvals News

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.

Algorae Pharmaceuticals has announced a non-renounceable Loyalty Options Offer to eligible shareholders, aiming to raise up to $337,678 before costs, with potential additional capital of $4.7 million if all options are exercised. The capital raise supports the company’s pharmaceutical and AI research and development ambitions.

Race Oncology has announced pivotal new clinical trials for its lead asset RC220, aiming to accelerate regulatory approval in Acute Myeloid Leukemia and tackle resistance in Non-Small Cell Lung Cancer.

TPG Telecom has launched a $688 million Reinvestment Plan offering new shares to eligible shareholders, aiming to offset the impact of a recent cash distribution and enhance market liquidity. The plan includes institutional and retail components priced at a discount, forming a key part of the company’s broader capital management strategy.

Tivan Limited has locked in a substantial $61.3 million equity investment from ETFS Capital, advancing the Speewah Fluorite Project in Western Australia and reinforcing its strategic partnerships with major Japanese stakeholders.

Radiopharm Theranostics has reached the halfway mark in enrolling patients for its Phase 2b trial of RAD101, a novel imaging agent targeting brain metastases. Early data suggest RAD101 may outperform MRI in distinguishing tumor recurrence from radiation damage.

Taiton Resources has received regulatory approval to commence drilling at the Yogi prospect within its Highway Project, targeting promising mineralisation in South Australia’s Gawler Craton. The maiden drill program aims to test a significant gravity anomaly indicative of IOCG or rare earth elements.

Prominence Energy Ltd has made significant technical progress at its Gawler Hydrogen Project, confirming high-grade natural hydrogen potential and preparing for a major geochemical survey in early 2026. The company also strengthens its global position by joining a prestigious hydrogen delegation to Korea.

Robex Resources reported a $16.5 million net loss in Q3 2025 and completed full drawdown of its $130 million project financing facility, progressing its Kiniéro gold project with a planned first gold pour in December. The company also announced a merger agreement with Predictive Discovery Limited, signaling strategic growth.

Horizon Minerals has agreed to sell its Lake Johnston Project to Forrestania Resources for $35 million, aiming to refocus on advancing its Black Swan gold operations.

Horizon Minerals has agreed to sell its Lake Johnston Project for $35 million to Forrestania Resources, aiming to bolster funding for its flagship Black Swan gold project. The deal combines cash and shares, positioning Horizon for growth and operational advancement.

Tamboran Resources has sanctioned its Shenandoah South Pilot Project, completed a record drilling campaign, and is progressing infrastructure to deliver gas to the Northern Territory by mid-2026. The company also announced a planned acquisition of Falcon Oil & Gas and raised $56 million in a public offering.