Latest Regulatory Decisions News

Memphasys has lodged regulatory submissions for its Felix™ System in Australia and India, following CE Mark approval, while progressing UK market entry under the CE Mark transition framework.

Pancontinental Energy has identified two new prospects in its PEL 87 permit, boosting its high case prospective resources to 6.1 billion barrels of oil net to the company. While progressing farmout discussions, the company awaits a critical permit extension decision from Namibian authorities.

Lumos Diagnostics reported a strong surge in FebriDx® sales alongside positive FDA feedback, securing full Medicare reimbursement and advancing key clinical studies.

MyEco Group Ltd has reported record quarterly sales of its MyEcoBag® products, alongside improved gross margins and a significant reduction in operating cash outflows following a strategic operational restructure.

Berkeley Energia reports promising metallurgical results from its Conchas critical minerals project in Spain while pursuing a US$1 billion arbitration over permitting delays at its Salamanca uranium project.

Manuka Resources is gearing up to recommence gold and silver production in the Cobar Basin by mid-2026 while awaiting a pivotal regulatory decision on its large-scale iron sands project in New Zealand.

Immutep Limited reports robust progress in its pivotal Phase III TACTI-004 trial for advanced non-small cell lung cancer, with over 120 clinical sites activated across 27 countries including the US. Patient enrolment has reached 38% of the target, keeping key milestones on track.

Telix Pharmaceuticals has dosed the first patient in the randomized expansion phase of its pivotal ProstACT Global Phase 3 trial for TLX591, targeting advanced prostate cancer. The trial is expanding globally, with regulatory submissions underway in the US and Europe.

Iris Cairns Property Pty Ltd has announced a delay in its takeover bid for Reef Casino Trust due to extended regulatory approval timelines, signaling a planned extension of the offer period beyond May 2026.

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.

PYC Therapeutics has secured Safety Review Committee approval to escalate dosing in its clinical trial for PYC-003, an RNA therapy targeting Polycystic Kidney Disease. This milestone moves the drug closer to pivotal Phase 2/3 trials.

Icon Energy Limited holds steady with $294,000 cash as it awaits key regulatory decisions on ATP 855 renewal and Petroleum Lease PL-1144, facing a looming ASX suspension deadline.