Latest Regulatory Submissions News

Resonance Health is progressing its MRI Liver Fibrosis device through late-stage clinical validation, targeting FDA biomarker qualification, while maintaining a profitable SaaMD platform and forecasting $16 million revenue for FY26.

Island Pharmaceuticals has kicked off GMP manufacturing of its antiviral Galidesivir to support late-stage Marburg virus studies under the FDA Animal Rule, marking a key step towards regulatory submission and biodefence readiness.

Bio-Gene Technology has expanded its capital raise to $2.775 million through a share placement priced at 2.5 cents, attaching options exercisable at 3.5 cents pending shareholder approval.

Paradigm Biopharmaceuticals has successfully raised $21.375 million through an oversubscribed Share Purchase Plan and a recent placement, bolstering its balance sheet ahead of key Phase 3 trial milestones.

Memphasys has inked its first exclusive commercialization agreement in South-East Asia with TMSC Vietnam, targeting the fast-growing Vietnamese IVF sector with its Felix™ sperm separation system. The two-year contract, valued at A$530,000, hinges on regulatory approval expected by August 2026.

Jade Gas Holdings has achieved a historic milestone with Mongolia’s first-ever approval of coal seam gas reserves, unlocking the path to commercial development of its TTCBM Project in the South Gobi.

Recce Pharmaceuticals has signed a non-binding term sheet with a major Middle Eastern pharma player for exclusive rights to commercialise its R327 Topical Gel across the MENA region, targeting a high diabetes burden market.

Bio-Gene Technology has raised A$3.21 million to complete critical safety studies for its novel insecticide Flavocide and ramp up production of its natural insecticide Qcide, advancing its path to commercialisation in multiple global markets.

Mt Malcolm Mines (ASX:M2M) is gearing up for a major drilling campaign at its Calypso Gold Prospect, aiming to convert a substantial Exploration Target into a JORC-compliant Mineral Resource. The program follows high-grade discoveries at the newly identified T3 Constance Lode and historical multi-lode mineralisation.

Vitrafy Life Sciences has achieved a major validation milestone with US Army-backed Phase II results showing its no-wash platelet cryopreservation protocol delivers 94% post-thaw recovery, outperforming existing standards and advancing FDA registration plans.

OncoSil Medical has clinched TGA approval for its OncoSil™ device, the first Class III medical device targeting pancreatic tumours in Australia, paving the way for local commercialisation and enhanced patient access.

Lumos Diagnostics advances US commercial rollout of FebriDx with positive reimbursement data and expanded urgent care adoption ahead of the 2027/28 flu season.