Latest Regulatory Engagement News

Alterity Therapeutics has raised A$40 million through a two-tranche placement to advance its lead compound ATH434 for neurodegenerative diseases, including Multiple System Atrophy and Parkinson's disease.

CLINUVEL has released preliminary data from its CUV052 study showing SCENESSE® is well tolerated in adolescent erythropoietic protoporphyria (EPP) patients, supporting a planned label extension in 2025.

Toro Energy reports steady progress in its Wiluna Uranium Project with updated resource estimates and ongoing native title consultations, positioning itself to capitalize on improving uranium market conditions.

Galan Lithium Limited advances its Hombre Muerto West project with a new mining permit and a significant resource upgrade at Candelas, positioning itself among the global lithium leaders and targeting production in H1 2026.

DigitalX Limited reported a 15% revenue increase in Q4 2024, driven by staking activities and performance fees, alongside a $10.3 million private placement and strategic Solana investment. The DigitalX Bitcoin ETF surpassed $50 million in funds under management, delivering a 67.4% quarterly return.

Following a recent unitholder meeting, One Managed Investment Funds Limited has initiated the orderly liquidation of the Fat Prophets Global Property Fund’s portfolio, signaling a significant transition for investors.

Mesoblast has secured FDA approval for Ryoncil®, the first mesenchymal stromal cell therapy for steroid-refractory acute graft versus host disease in children, while raising A$260 million to accelerate clinical trials and commercial rollout.

Hartshead Resources reports a robust December quarter with strategic progress on UK gas developments, fiscal clarity from government levy changes, and the acquisition of new licenses boosting its resource base.

Winsome Resources has filed a key Technical Report for its Adina Lithium Project and extended payment terms for the Renard Operation acquisition, marking significant progress in project development and regulatory engagement.

BlinkLab has launched its pivotal FDA registrational study for its AI-driven autism diagnostic app, BlinkLab Dx 1, following positive FDA feedback and promising preliminary results.

Carbine Resources reports steady progress on its Muchea West silica sand mining licence application, engaging environmental consultants to support upcoming approvals. The company also continues exploration efforts at its Down South project.

Argenica Therapeutics has dosed 80% of patients in its Phase 2 stroke trial and gained FDA orphan drug designations for its second candidate, ARG-006. The company reports a cash-positive quarter with $15 million in reserves.