Latest Regulatory Milestones News

Cleo Diagnostics (ASX:COV) has hit a major milestone by completing sample collection for its pivotal U.S. ovarian cancer trial, while progressing manufacturing and analytical validation steps toward FDA 510(k) submission.

Sky Metals has bolstered its cash reserves with a $20.5 million raise, backing a major drilling push at Tallebung and expanding exploration at Doradilla, positioning both projects for significant resource growth and development progress.

Invictus Energy is gearing up for a pivotal drilling campaign in Zimbabwe's Cabora Bassa Basin, targeting a multi-Tcf gas and condensate resource that could reshape Southern Africa's energy landscape.

Argenica Therapeutics is progressing its ARG-007 drug toward a targeted Phase 2b trial for acute ischaemic stroke, leveraging AI for patient selection and securing key regulatory approvals, while maintaining a solid cash position of $8 million.

Anteris Technologies has gained U.S. Medicare reimbursement eligibility for its pivotal PARADIGM Trial, clearing a key hurdle for clinical site activation and accelerating its transcatheter heart valve study.

Lake Resources made solid progress on the Exploitation Environmental Impact Assessment for its Kachi Lithium Brine Project, targeting approval in Q3 2026, while maintaining strong liquidity and strategic partnerships.

Atomo Diagnostics capitalises on Lumos Diagnostics’ FebriDx FDA CLIA waiver with over $2 million in new sales orders and a $3 million capital raise, expanding its global footprint and product pipeline.

Amplia Therapeutics reported mature ACCENT trial data showing improved survival and multiple complete responses with narmafotinib, alongside a GMP production milestone and CFO appointment.

OncoSil Medical reported a 60% year-on-year increase in dose sales in Q3 FY26, boosted by expanding treatment centres and advancing clinical trials, while cost-cutting and a new manufacturing facility aim to underpin growth.

Algorae Pharmaceuticals has struck an exclusive commercial and licensing agreement with global pharma Zydus Lifesciences to bring 10 injectable, oral, and specialty medicines to Australia and New Zealand, pending regulatory approvals.

Cleo Diagnostics has kicked off a staged manufacturing program with Bio-Techne to produce ovarian cancer test kits, moving from clinical sample collection to analytical validation and FDA submission preparation.

Singular Health boosted its US presence by deploying 500 additional 3DICOM MD® licenses to Provider Network Solutions, securing FDA 510(k) clearance for its cloud platform, and launching education pilots with Miami-Dade schools and Florida International University.