Latest Regulatory Submissions News

Neurotech International has received Notices of Allowance from the USPTO for two patents covering its lead drug NTI164, reinforcing its intellectual property position as it advances Phase 3 trials for autism spectrum disorder.

AdAlta has met a key US$1 million milestone payment under its China collaboration, gaining critical clinical data and securing proprietary materials for Australian manufacturing of its lead CAR-T therapy BZDS1901.

Truscreen Group has issued nearly 150 million new shares at NZ$0.013 each, expanding its share base by 17.4% following a renounceable rights issue. The fully paid shares rank equally with existing stock, lifting total ordinary shares to just over one billion.

Neurizon Therapeutics has secured a critical five-year supply agreement with Elanco Animal Health for GMP-grade monepantel, underpinning the commercialisation readiness of its lead ALS drug candidate NUZ-001.

Island Pharmaceuticals is accelerating development of its broad-spectrum antiviral Galidesivir, progressing clinical, regulatory, and manufacturing milestones under the FDA Animal Rule pathway with expanded USAMRIID collaboration and biodefence positioning.

Imricor Medical Systems has submitted the third of four Premarket Approval modules to the FDA, marking a key step towards US approval of its MR-guided cardiac ablation devices.

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.