Latest Regulatory News

Invion Limited has affirmed its compliance with ASX disclosure rules following the US FDA’s granting of Orphan Drug Designation for its anal cancer treatment candidate INV043. The company detailed the timing and verification process behind its announcement.

Zoono Group Limited reported a 19.1% revenue increase to NZ$1.25 million for FY2025, alongside a significantly reduced net loss. The company is pivoting towards B2B markets, focusing on antimicrobial and shelf-life extension technologies, supported by a recent AUD 1.78 million capital raise.

Stellar Resources has reported a significant tin discovery at its Severn deposit, revealing a high-grade core that could expand and upgrade the Heemskirk Mineral Resource Estimate. The company is accelerating drilling and prefeasibility studies, signaling strong growth potential.

Tetratherix Limited reports its first financial results as a listed company, revealing a $9.4 million statutory loss driven by R&D and listing costs, alongside a robust $29.3 million cash position post-IPO. The company highlights key operational milestones and outlines strategic plans to accelerate commercialisation across its innovative biomaterial platform.

Perpetual Limited reported a steady FY25 with underlying profit after tax of $204.1 million, revenue growth across all segments, and a net loss narrowed to $58.2 million. The firm’s refreshed strategy focuses on simplification, operational excellence, and measured growth investments amid evolving regulatory landscapes.

Lynas Rare Earths has launched a fully underwritten A$750 million equity raising to fund its ambitious Towards 2030 growth strategy, aiming to expand rare earths production and downstream capabilities outside China.

Dimerix Limited reported a 22% reduction in its FY2025 loss to $13.25 million, driven by strong licensing revenues and advancing its pivotal Phase 3 clinical trial for DMX-200. The company secured new global partnerships valued at up to AU$1.4 billion, bolstering its cash reserves and commercial prospects.

BetMakers Technology Group delivered a strong FY25 with a 5.6% half-on-half revenue growth and record profitability, while advancing its technology transformation and signing a strategic acquisition in Nevada.

Telix Pharmaceuticals has received a Complete Response Letter from the FDA for its TLX250-CDx diagnostic agent, citing manufacturing concerns. The company plans immediate remediation and maintains its 2025 revenue guidance.

Emyria Limited reports a reduced net loss of $3.14 million for FY2025, driven by strategic expansion in psychedelic-assisted mental health treatments and key partnerships including insurer Medibank. The company advances clinical services while continuing R&D on proprietary medicines.

BetMakers Technology Group reported a 10.6% revenue decline to $85.1 million for FY25 but achieved positive adjusted EBITDA and operating cash flow for the first time, signaling a strategic turnaround.

Comms Group Limited reported a 2.1% revenue increase to $56.6 million for FY25, driven by organic growth and the strategic acquisition of TasmaNet. Despite this, underlying EBITDA declined 13.6%, reflecting investments and one-off revenue adjustments.