Latest Regulatory Engagement News

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.

Alterity Therapeutics has announced encouraging Phase 2 trial results for ATH434, showing significant slowing of disease progression in multiple system atrophy (MSA) patients and a strong safety profile. These findings mark a potential breakthrough in treating a disease with no approved therapies.

Neurotech International reports key clinical progress in paediatric neurological disorders, securing FDA orphan drug designation for its Rett Syndrome treatment and advancing pivotal trials for ASD and PANDAS/PANS.

PYC Therapeutics reports substantial progress across all four of its drug development programs in Q4 2024, including key regulatory designations and clinical milestones that set the stage for pivotal trials in 2025.

Noronex Limited has lodged applications for two expansive Prospecting Licences in Botswana adjacent to its active Damara Copper Project in Namibia, signaling a strategic push into new, unexplored terrain within the Kalahari Copper Belt.