Latest Regulatory Approvals News

Nickel Industries surged to a US$74 million profit in H1 2026, driven by higher nickel prices, expanded mining quotas, and strategic HPAL investments including first nickel cathode production at ENC.

TALi Digital Limited (ASX: TD1) posted a 416% jump in revenue for FY26 but also recorded a $2.2 million loss driven by a $1.3 million impairment of its YCDI! intangible assets. The company is pursuing growth through AI-focused acquisitions and a $3.3 million capital raise.

Genetic Signatures (ASX: GSS) and Microba Life Sciences (ASX: MAP) are in early talks about merging to form a larger infectious disease diagnostics entity, combining rapid pathogen detection with microbiome profiling. The proposed group would have FY2026 pro forma revenue of around A$29 million and a stronger financial footing.

Acrux Limited reported a 46% revenue increase to $6.6 million in FY26, driven by US generic product royalties and licensing milestones, while narrowing its net loss by 90%. The company is pivoting towards developing a female testosterone therapy with encouraging Phase II data and active regulatory engagement.

Neuren Pharmaceuticals reported an 8% rise in H1 2026 revenues driven by DAYBUE royalties, but profit fell 68% due to ramped-up R&D. The company declared its first ever dividend, signalling confidence amid ongoing clinical and regulatory milestones.

Prescient Therapeutics (ASX:PTX) has opened a $7 million Share Purchase Plan at a significant discount to advance its lead cancer therapy PTX-100 beyond a pivotal Dose Optimisation Committee review in late 2026.

Epiminder Limited reported a $42.7 million loss for FY26, driven by clinical trial and product development costs following a $125 million IPO. The company progresses its FDA-approved Minder implantable EEG monitor with a pivotal US trial and next-gen device on track for 2028 launch.

Cavalier Resources has chosen SSH Group as its preferred mining contractor for the initial oxide pit at the Crawford Gold Project, aiming to kickstart mining operations within the next year.

HiTech Group has secured unconditional ACCC clearance for its acquisition of Hudson Global Resources’ Australian assets, removing a major regulatory obstacle ahead of completion.

PolyNovo reported a 16.1% rise in FY26 revenue to AUD 150 million, driven by strong global sales and manufacturing expansion, yet net profit fell 44% due to a significant asset write-off from an R&D centre fire and lower tax benefits.

Vysarn Limited reported a robust 31.5% increase in revenue to $140 million for FY2026, driven by strong performances across its industrial, advisory, and technology segments. The company is accelerating its national footprint with strategic acquisitions and progressing the Kariyarra Water Scheme.

Winton Land reported a 120% rise in net profit to $22.7 million in FY26, driven by increased residential settlements and full-year trading at its hospitality venues, despite economic headwinds and leadership changes.