Latest Regulatory Approval News

NeuroScientific Biopharmaceuticals reported a $1.85 million loss for FY25, driven by reduced R&D incentives and increased development costs following its acquisition of StemSmart™ technology. The company is advancing clinical programs, including a Special Access Scheme for Crohn’s disease.

HPP has agreed to acquire Red Earth Energy Storage in a $40 million merger, aiming to relist on the ASX by early 2026 and capitalize on Australia’s growing battery storage market.

Argenica Therapeutics reported a 34% revenue increase driven by R&D incentives but saw losses widen by 31% due to intensified clinical trial activity. The company is progressing its ARG-007 Phase 2 stroke trial and engaging with the FDA to lift a clinical hold.

Mad Paws Holdings reported a $12.27 million loss for FY25, deepening from last year, as it divests its Pet Chemist business and agrees to a $62 million acquisition by Rover Group.

Clarity Pharmaceuticals reported a $64.3 million loss for FY2025 alongside significant clinical progress and a $203.6 million placement to fund its radiopharmaceutical pipeline expansion.

Reef Casino Trust and Iris Cairns Property Pty Ltd have agreed to increase the takeover bid price to $3.87 per unit, boosting the total offer value to approximately A$192.7 million. The unanimous board recommendation and major unitholder support underscore the deal’s momentum amid regulatory conditions.

Clinuvel Pharmaceuticals has reported a robust financial year ending June 2025, marked by solid revenue growth and sustained profitability, while advancing its clinical pipeline and maintaining a strong balance sheet.

EMVision Medical Devices reported a sharp increase in FY25 losses alongside a 51% revenue drop, yet marked significant progress in clinical trials for its innovative brain scanners and secured $8 million in government grants to fuel commercialisation.

Clinuvel Pharmaceuticals reports steady financial growth with an 8% rise in revenue and 2% profit increase, while expanding its US commercial footprint and completing recruitment for a pivotal vitiligo trial.

IRIS Metals has agreed to sell its Kookynie Gold Project to Arika Resources, securing cash and equity to fuel its lithium ambitions in the US. This strategic move realigns IRIS’s portfolio towards critical minerals while retaining exposure to Kookynie through Arika shares.

Tetratherix Limited advances its Tetramatrix biomaterial platform with a robust IP portfolio, scalable manufacturing, and strategic partnerships aimed at commercialising across multiple clinical franchises.

SomnoMed Limited reported a record FY25 with $111.5 million revenue and a return to positive EBITDA, marking a milestone of over one million patients treated globally. The company secured FDA clearance for its Rest Assure® compliance tracking device and provided optimistic guidance for FY26.