Latest Regulatory Approvals News

Zelira Therapeutics reported a significantly reduced loss of AUD 3.85 million for FY25, driven by clinical progress and strategic funding for its HOPE® cannabinoid medicines. The company also expanded its patent portfolio and commercial footprint across key markets.

OncoSil Medical reported a $15.1 million loss for FY25 amid strong revenue growth and significant regulatory milestones, supported by over $14 million in capital raises to fuel its global expansion.

Orthocell Ltd reported a record $9.23 million revenue for FY25, driven by strong sales of its nerve repair and dental products, alongside securing US FDA clearance for its flagship nerve repair device Remplir. The company is poised for accelerated growth as it expands its global commercial footprint.

Echo IQ Limited reported a sharp increase in losses for FY25 despite revenue growth, while securing FDA clearance and expanding its AI-driven cardiology platform across major US networks.

Tissue Repair Ltd reported a 27.3% revenue increase to $3.22 million for FY25, driven by new distribution deals and regulatory progress, while continuing to invest heavily in clinical trials and manufacturing scale-up, resulting in a $4.24 million loss.

Infinity Mining Limited’s 2025 AGM highlighted significant portfolio reshaping, including asset sales and acquisitions, alongside promising exploration results at the Cangai Copper Project.

Prescient Therapeutics has completed a $3 million share placement, bolstering its clinical development programs for innovative cancer treatments including PTX-100 and novel cell therapies.

Alligator Energy Limited offers Placement Participants up to 278 million options exercisable at $0.047 each, following a $17.25 million placement completed in June 2025. The options offer closes on 8 September 2025 and is exclusive to Placement Participants.

Resonance Health reports robust FY25 results with 29% revenue growth and outlines ambitious FY26 guidance targeting $17 million in revenue and $2 million EBITDA. The company’s transformation into three profit-generating segments underpins its expanding footprint in the global clinical trial ecosystem.

Alterity Therapeutics reported a reduced net loss of A$12.15 million for FY2025, buoyed by positive Phase 2 clinical trial results for its lead drug ATH434 in Multiple System Atrophy and a successful A$40 million capital raising.

Bathurst Resources reports a dip in FY25 earnings due to lower coal prices and operational challenges but pushes forward with key development projects Buller and Tenas, targeting production growth from FY29.

4DMedical reports a robust 56% revenue increase in FY2025, driven by SaaS expansion and strategic partnerships, while advancing FDA clearance for its innovative CT – VQ™ lung imaging software.