Latest Regulatory Approvals 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.

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.

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.

Imricor Medical Systems has submitted its NorthStar Mapping System for FDA pediatric label expansion, aiming to accelerate adoption in over 250 US children’s hospitals and broaden its commercial footprint.

Predictive Discovery Limited (ASX: PDI) and Robex Resources Inc. (ASX: RXR) have confirmed their merger is unconditional and moving to implementation, forming a significant West African gold producer with combined assets targeting over 400,000 ounces of gold production annually by 2029.

Zenith Minerals (ASX: ZNC) has commenced an eight-hole reverse circulation drilling program at its Consolidated Dulcie Gold Project, aiming to grow and enhance its recently defined 675,000 ounce inferred gold resource. The campaign targets near-resource zones and strategic gaps along a 6 km mineralised corridor, while regional exploration efforts continue.

National Storage REIT (ASX:NSR) has confirmed satisfaction of key foreign investment conditions for its proposed acquisition by a Brookfield-GIC consortium, with securityholder meetings scheduled for mid-April.

Archer Materials has progressed its Biochip program by completing the alpha prototype and Stage 1 project with IMEC, now advancing to develop a beta prototype suitable for external use and clinical validation.

Mesoblast Limited (ASX:MSB, Nasdaq:MESO) reported net sales of US$30.3 million for its FDA-approved cellular therapy Ryoncil in the March quarter, bringing total revenue since launch close to US$100 million. Strong sales in February and March offset January’s seasonal dip.

Memphasys Limited (ASX: MEM) announced an investor webinar and released an updated presentation detailing its transition from early-stage commercialisation to scaling global revenues, highlighting multi-market sales, recurring cartridge revenue, and regulatory progress.

Elanor Investors Group has completed documentation for a $125 million balance sheet recapitalisation with Rockworth Capital Partners, preparing to release HY26 financial results and advance leadership renewal and rebranding initiatives.