Latest Regulatory Approvals News

Recce Pharmaceuticals reported a 21% increase in net loss to $21.4 million for FY2025, driven by intensified R&D spending. The company secured key regulatory approvals for Phase 3 trials of its lead anti-infective gel and bolstered its financial position with significant capital raises and grants.

HALO Technologies reports a significantly improved half-year net loss and secures verbal FCA approval for its UK platform, while preparing to launch Managed Funds in Australia.

TerraCom Limited reported a statutory loss of A$33.7 million for FY2025 amid lower coal sales and prices, while progressing its Moorlands Thermal Coal Project in partnership with Wintime Energy Group.

Argent BioPharma reported a net loss of A$17.84 million for FY2025, reflecting a strategic pivot towards core drug development and clinical advancement. The company secured key EU approvals and raised significant capital to support its neuro-immune modulatory pipeline.

Osteopore Limited reported a 6% increase in revenue to $1.56 million for the half-year ended June 2025, alongside a slight rise in net loss driven by expanded product development and compliance costs. The company secured key regulatory approvals and broadened its distribution footprint in Asia and the US.

Chimeric Therapeutics reported a reduced net loss of $10.43 million for FY2025, driven by cost efficiencies and strategic project reprioritisation, while making significant clinical progress in its CAR T-cell and NK cell therapy programs.

TPC Consolidated Limited reported a robust 20.9% increase in revenue to $193.1 million for FY25, driven by growth in electricity and gas services. However, net profit after tax plunged 94.4% to $0.3 million, reflecting the impact of volatile wholesale electricity prices and rising costs, while a proposed acquisition awaits regulatory approval.

Uscom Limited reported a 25% decline in revenue to $3.16 million and a 59% increase in net loss to $3.3 million for FY25, reflecting significant global headwinds. Despite setbacks, the company advanced new product approvals and secured funding to navigate ongoing challenges.

Cambium Bio reported a $3.84 million loss for FY25 but secured critical FDA approvals and ethics clearances to initiate Phase 3 trials of Elate Ocular®, supported by a $2.12 million capital raise.

Firebrick Pharma reported a substantial increase in Nasodine Nasal Spray revenues in FY25, alongside a widening net loss driven by reduced R&D incentives and increased marketing investments. The company is advancing its international rollout with new licensing deals and board appointments.

Environmental Clean Technologies Limited reported a $3.52 million net loss for FY2025, marking a modest 5% improvement, while making significant progress in commercialising its COLDry fertiliser technology and securing over $1.7 million in new capital.

Iris Cairns Property Pty Ltd has lodged a bidder’s statement for an all-cash $3.87 per unit takeover offer for Reef Casino Trust, securing unanimous recommendation from the trust’s board and major unitholders. The offer, representing a significant premium, awaits regulatory approvals and closes in March 2026.