Latest Regulatory Changes News

Tissue Repair advances its US Phase III chronic wound trial with 100 patients randomised and targets October FDA 510(k) submission. The company reports a robust cash position bolstered by R&D refunds and has cut manufacturing scale-up costs.

Novatti Group Limited delivered a 5% quarter-on-quarter revenue increase to $7.6 million in Q4 FY26, driven by its Payments AU/NZ segment's strong 8% revenue and 26% margin growth. The company achieved positive EBITDA of $0.3 million, boosted by a 95% jump in Payments AU/NZ EBITDA to $0.9 million.

Predictive Discovery reported a 33% increase in gold production to 64,026 ounces in Q2 2026, driven by Kiniero’s operational ramp-up and advancing development at the Bankan project.

Avecho Biotechnology has secured a unanimous recommendation to continue its Phase III insomnia trial without increasing sample size, alongside raising $1.9 million through option exercises and bolstering its cash position to $6.6 million.

Emyria has expanded its Empax clinic network across four states, reporting a 210% revenue increase in FY26 and early clinical success in treatment-resistant depression.

EDU Holdings has delivered record first-half 2026 results, driven by a 57% jump in Higher Education enrolments at Ikon, lifting revenue by 48% and profit before tax by 57%.

Syrah Resources moderated graphite output amid subdued ex-China demand, raised US$72 million to support ramp-up, and advanced Vidalia anode material towards commercial sales in H2 2026.

Monvia Limited, an Australian SaaS provider for life insurers, is seeking to raise $17.5 million via an IPO on the ASX. The funds will support redemption of preference shares and fuel growth in existing and new markets.

Unith Ltd (ASX:UNT) is raising up to $1.75 million through a non-renounceable entitlement offer priced at 0.8 cents per share, accompanied by free-attaching listed options, aiming to accelerate technology and commercial development.

Sweden has enacted legislation removing uranium mining from nuclear facility regulations, easing Aura Energy's path to develop its Häggån deposit without needing municipal consent.

Mayfield Childcare has pulled its FY26 earnings guidance amid rising costs and regulatory shifts, while cautiously advancing its Mayfield 360 allied health initiative.

Qoria Limited marked a turning point in FY25, delivering 25% growth in Annual Recurring Revenue and a 684% jump in underlying EBITDA, setting sights on 20% EBITDA margin in FY26 amid global digital safety expansion.