Latest Regulatory Approvals News

Race Oncology has received ethics approval to launch its HARNESS-1 Phase 1a/b trial testing RC220 combined with osimertinib in EGFR-mutated non-small cell lung cancer patients, marking a key step toward addressing resistance to current therapies.

Patrys Limited has expanded its clinical pipeline by acquiring Reliis Pty Ltd, gaining a proprietary injectable formulation of Quetiapine aimed at the large and underserved delirium market. This strategic move balances Patrys’ portfolio with a near-term pharmaceutical asset alongside its biologics program.

Sarytogan Graphite Limited has raised $1.8 million through a placement to fund its Definitive Feasibility Study and advance key project development activities at its strategic graphite deposit in Kazakhstan.

Syntara Limited has successfully completed Phase 1a trials for its topical anti-fibrotic drug SNT-9465, demonstrating dose-dependent target engagement and safety, and is now progressing to an innovative Phase 1b study in hypertrophic scars.

Mammoth Minerals has identified a major new 5.5km by 4.2km intrusive complex at its Excelsior Gold Project in Nevada, drawing parallels to the prolific 4.2Moz Goldfield Caldera. Concurrent surveys at its Skyline Project in Canada bolster its base metals exploration pipeline, while plans for a strategic spinout are underway.

Cleo Diagnostics has secured a $1.7 million R&D tax refund, strengthening its cash reserves to $5.75 million as it advances toward a pivotal US clinical trial and FDA submission for its ovarian cancer test.

New Frontier Minerals advances its Harts Range heavy rare earths project with imminent drilling and secures a strategic alliance to develop its NWQ copper assets, positioning itself strongly in critical minerals supply.

Neometals Ltd and partner Omaha Value have secured a 60-day exclusive option to evaluate lithium and potash brines from historic oil and gas wells in Utah’s Paradox Basin, aiming to leverage existing infrastructure for accelerated critical minerals exploration.

Elixir Energy has raised approximately AUD 16.6 million through a two-tranche placement led by Omega Oil & Gas, aiming to fast-track its Taroom Trough gas projects and advance toward commercial production.

Impact Minerals Limited has announced a 10, 1 consolidation of its securities, including ordinary shares, options, and performance rights, pending security holder approval. This restructuring aims to streamline the capital structure ahead of December trading.

Entertainment Rewards Ltd has issued a Target’s Statement recommending shareholders accept Suzerain Investment Holdings’ conditional off-market takeover offer at a significant premium. An independent expert concurs the offer is fair and reasonable, setting the stage for potential full ownership by Suzerain.

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.