Latest Regulatory Approval News

Lindian Resources has secured exclusive rights to over 13,000 tonnes of heavy rare earth feedstock in Kazakhstan, aiming to boost output at its wholly owned SARECO processing facility with dysprosium, terbium, and yttrium-rich material.

EMVision has accelerated recruitment in its pivotal emu™ brain scanner trial, surpassing 200 patients and advancing FDA discussions to broaden clinical endpoints, setting the stage for regulatory submission in early 2027.

BetMakers Technology Group Ltd (ASX: BET) reported solid FY26 financial results with revenue up 8.8% to $92.6 million and adjusted EBITDA surging 205% to $14.1 million. The company also announced a binding acquisition scheme with Tabcorp Holdings Limited.

Ceretas Limited posted a $1.63 million net loss for FY26 on $1.28 million revenue from government grants, advancing its clinical-stage Alzheimer’s ultrasound platform. The company completed an $8 million IPO in July to fund pivotal trials and device development.

Argent Minerals has secured regulatory approval to launch its first-ever drilling program at the Trunkey Creek Gold Project in NSW, targeting a 4.7km high-grade gold corridor. The initial 1,000m Phase 1 campaign aims to test priority underground targets beneath historic workings.

Strike Energy has secured Hancock Energy's Belisama facility as the preferred processing partner for West Erregulla gas and agreed on up to $30 million in funding to advance development, targeting first gas by mid-2029.

Brazilian Critical Minerals (ASX: BCM) has engaged Altris Engineering to spearhead the Front-End Engineering and Design (FEED) phase of its Ema Rare Earth Project, aiming to advance the project from feasibility towards financing and construction readiness.

Singular Health Group lifted revenues over fivefold to $1.43 million in FY26, driven by US commercial rollouts of its 3DICOM platform, but posted a $6.34 million loss. The company strengthened its US foothold with FDA clearance and a controlling stake in an associate.

PYC Therapeutics strengthened its financial footing with a $600 million capital raise and made notable clinical progress across four RNA therapeutic programs targeting genetic diseases.

Cambium Bio has secured FDA agreement on a streamlined single pivotal Phase 3 trial for Elate Ocular®, cutting development costs and timelines. Despite a AUD 4.1 million loss for FY2026, the company strengthened its funding position and manufacturing partnerships ahead of patient dosing targeted for late 2026.

OncoSil Medical lifted revenues 44% in FY26 to $1.68 million and trimmed losses by 28% to $10.86 million, buoyed by key regulatory approvals including FDA HDE and Australian TGA listings. The company is poised for commercial launches in the US and Australia, with strong clinical data underpinning its growth.

Alterity Therapeutics posted a 285% jump in revenue to A$1.72 million but also a 93% rise in net loss to A$23.4 million for FY2026. The company secured FDA alignment on a single pivotal Phase 3 trial for ATH434 in Multiple System Atrophy, setting the stage for trial start by year-end.