Latest Regulatory Engagement News

Arovella Therapeutics reported a robust $20.9 million cash position as it prepares for its first-in-human trial of ALA-101 and expands its solid tumour pipeline through new licensing agreements and leadership appointments.

MyEco Group reported an 8.6% increase in FY25 sustainable product sales, driven by strong growth in its MyEco® brand globally. The company is executing an operational restructure expected to deliver $2.5 million in cost savings in FY26 while navigating volatile resin markets and US tariff uncertainties.

Pantera Lithium Limited has agreed to sell its Smackover Lithium Project subsidiary to Energy Exploration Technologies Inc. for A$40 million, significantly strengthening its financial position and strategic exposure to U.S. lithium assets.

PYC Therapeutics reports solid progress across its four RNA therapeutic programs targeting genetic diseases, backed by a strong cash position extending runway beyond 2027.

The Virginia Supreme Court has affirmed the State Corporation Commission’s decision to deny a toll rate increase for the Dulles Greenway, owned by Atlas Arteria. Meanwhile, a related federal case alleging constitutional violations will now proceed.

Imugene Limited has launched a A$37.5 million capital raising to advance its promising off-the-shelf CAR T therapy, azer-cel, following encouraging Phase 1b data showing a 75% overall response rate in lymphoma patients.

EBR Systems has received preliminary approval from the U.S. Centers for Medicare & Medicaid Services for outpatient reimbursement of its WiSE® CRT System, marking a major step toward broader hospital adoption.

Imagion Biosystems has received encouraging feedback from the FDA on its planned Phase 2 HER2 breast cancer clinical trial, paving the way for its Investigational New Drug application submission later this year.

Argent BioPharma has begun supplying its EU-GMP cannabinoid API for drug-resistant epilepsy treatment at University Medical Centre Ljubljana, marking a key clinical and regulatory milestone in Europe.

Netlinkz Limited reports $2.4 million in quarterly receipts and announces a strategic joint venture in the Philippines, enhancing its cybersecurity footprint in the ASEAN region with innovative network solutions.

Actinogen Medical has enrolled its 100th participant in the XanaMIA phase 2b/3 Alzheimer’s trial, setting the stage for a critical interim analysis in January 2026 and final results by year-end.

GTN Limited is set to seek shareholder approval for a substantial $44 million capital return, aiming to reward investors without compromising its dividend policy.