Latest Regulatory News

Mesoblast Limited (ASX:MSB, Nasdaq:MESO) has received FDA Investigational New Drug clearance to initiate a pivotal clinical trial of its cell therapy Ryoncil in children with Duchenne Muscular Dystrophy, aiming to address inflammation-driven disease progression.

Insignia Financial has received Foreign Investment Review Board approval for its proposed acquisition by Daintree BidCo, clearing a key regulatory hurdle. The scheme now awaits shareholder and court approvals, with the board recommending shareholder support.

Tamboran Resources Corporation has initiated a significant equity raise totaling approximately US$198 million to fund expanded drilling and development activities in the Beetaloo Basin. The capital raise includes a registered underwritten public offering and a pro rata entitlement offer, representing a 25% increase in shares on issue.

Tamboran Resources Corporation has initiated an underwritten public offering of nearly 3 million shares to support expanded drilling and resource delineation in the Beetaloo Basin, alongside a concurrent institutional entitlement offer.

Multistack International Limited (ASX:MSI) has agreed in principle to sell all its assets and liabilities to Hong Kong-based Willing Y Limited, marking a significant strategic shift as MSI plans to discontinue its current business and explore new opportunities.

Rent.com.au Limited has clarified the timing and materiality of its recent Senior Debt Facility increase and extension, responding to an ASX query. The company also addressed insider trading compliance related to director share purchases in March 2026.

Neuren Pharmaceuticals’ partner Acadia Pharmaceuticals has broadened availability of DAYBUE STIX, a new FDA-approved powder formulation of trofinetide for Rett syndrome, in the US. Early caregiver feedback and expert consensus highlight its potential role in personalised patient care.

Fulcrum Lithium Ltd has completed its largest Phase 3 drilling program at the Alkali Flats project in Nevada, confirming extensive lithium mineralisation with multiple thick intersections and assay results pending to further define the resource.

InFocus Group Holdings Limited (ASX: IFG) has unveiled a global technical preview of Codexa, its proprietary sweepstakes casino platform, marking a key step towards commercial operations in the US market. The platform features advanced technology including blockchain fairness verification and AI-driven personalisation.

Sequoia Financial Group Ltd has admitted to unintentionally breaching ASX Listing Rule 15.7 after its CEO disclosed details of the InterPrac Financial Planning sale to a journalist during a trading halt. The company is reviewing its continuous disclosure practices to prevent future occurrences.

Aguia Resources’ Brazilian subsidiary has achieved a key regulatory milestone with official fertiliser registration, enabling commercial sales of its PAMPAFOS phosphate product in Brazil’s large agricultural market.

Radiopharm Theranostics has received a positive recommendation to escalate the dose of its 177Lu-RAD202 radiotherapeutic in a Phase 1 trial targeting HER2-positive advanced solid tumors, maintaining its timeline to complete dose escalation by year-end 2026.