Latest Regulatory Decisions News

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.

St Barbara Limited reports steady progress on its Simberi Expansion Project in Papua New Guinea and Atlantic Gold Projects in Canada, despite production challenges and pending regulatory decisions. A recent A$58 million capital raise strengthens its financial position for growth.

Imricor Medical Systems made significant regulatory strides with FDA submissions for its MRI-guided cardiac ablation devices and launched NorthStar commercially in Europe, even as it reported increased cash outflows in Q3 CY25.

Dimerix’s latest PARASOL collaboration analysis reinforces proteinuria as a pivotal endpoint in their Phase 3 FSGS trial, setting the stage for FDA discussions on accelerated approval pathways.

Bod Science Limited has reported a notable profit turnaround for FY2025, driven by medicinal cannabis sales growth, while navigating a complex Deed of Company Arrangement and a proposed backdoor listing with Biortica Agrimed Limited.

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.

The European Medicines Agency has approved continuous bi-monthly dosing of CLINUVEL’s SCENESSE® for adult erythropoietic protoporphyria patients, removing previous annual dose limits and aligning Europe with US treatment standards.