Latest Regulatory Engagement News

Hot Chili Limited expands its Costa Fuego copper-gold project with significant drilling success at La Verde, underpinning a strong Preliminary Feasibility Study and strategic water infrastructure plans.

Berkeley Energia has reported a maiden inferred lithium and rubidium resource at its Conchas Project in Spain, alongside appointing former Endesa CEO José Bogas Gálvez to its board, while continuing a US$1.25 billion arbitration against Spain over its Salamanca uranium project.

Avecho Biotechnology has secured a unanimous recommendation to continue its Phase III insomnia trial without increasing sample size, alongside raising $1.9 million through option exercises and bolstering its cash position to $6.6 million.

AdAlta has completed a key US$1 million milestone payment securing rights to its lead CAR-T therapy EW-001 outside Greater China, progressed Australian manufacturing with first runs expected late 2026, and is preparing for a critical pre-IND meeting with the US FDA.

LTR Pharma’s SPONTAN shows rapid absorption in Phase II interim data while securing key US commercial deals for ROXUS, setting the stage for a US market entry later this year.

Nyrada has dosed the first patient in its Phase IIa trial of Xolatryp targeting heart attack recovery, while strengthening its cash reserves and receiving a US patent allowance for its lead drug.

CLINUVEL Pharmaceuticals is relocating its corporate headquarters to the United States and reducing its global workforce by up to 20%, realigning its operations to focus solely on the US pharmaceutical market and unlock greater capital access.

Macquarie Group reports a 30% profit increase in FY26 to A$4.85 billion as CEO Shemara Wikramanayake announces retirement, with Greg Ward set to take the helm in November 2026.

Entropy Neurodynamics has reported breakthrough Phase 2 clinical results for its intravenous psilocin therapy in treatment-resistant Binge Eating Disorder, alongside strong Phase 2a data in Irritable Bowel Syndrome and a new US patent filing.

Noxopharm reported significant progress in its Sofra technology, highlighting enhanced cancer drug potential and preparations for a US FDA clinical trial, while managing tight cash reserves.

Ceretas Limited is raising $8 million through an IPO to fund clinical trials and development of its novel therapeutic ultrasound device targeting Alzheimer’s disease symptoms.

CONNEQT Health's June quarter saw record consumer revenue growth and a 70% jump in enterprise subscription ARR, supported by a $5.5 million placement and progress on its FDA regulatory pathway for its cloud-based vascular analytics platform.