Latest Regulatory Pathways News

Immutep Limited reveals promising Phase II results from its AIPAC-003 trial, establishing 30 mg as the optimal biological dose of eftilagimod alfa combined with paclitaxel in metastatic breast cancer patients.

Singular Health has submitted a 510(k) premarket notification to the FDA for its enhanced 3DICOM MD Cloud platform, aiming to expand imaging capabilities and introduce a scalable, cloud-native solution for medical image management.

Amplia Therapeutics reported a $4.18 million half-year loss but bolstered its cash reserves with a $27.6 million capital raise to advance clinical trials of its lead drug narmafotinib, showing encouraging interim data in pancreatic cancer.

The Federal Court of Australia has approved the acquisition scheme for Lynch Group Holdings, paving the way for a cash payout to shareholders and imminent trading suspension.

Recce Pharmaceuticals has secured a key patent in Hong Kong for its synthetic anti-infectives, reinforcing its intellectual property footprint in Asia and supporting its clinical and commercial ambitions in the region.

ReNerve Ltd reports a strong 53% year-on-year revenue increase, expanding its US distribution network and advancing clinical studies for its nerve repair products. The company is poised for significant global market growth with new partnerships and upcoming product launches.

InhaleRx Limited has introduced SRX-25, an oral fixed-dose combination therapy targeting Treatment-Resistant Depression, aiming to improve patient access and adherence. The company also secured $1 million in capital to advance clinical development and plans a strategic rebrand.

Recce Pharmaceuticals has reported compelling preclinical results for its inhaled anti-infective RECCE 327, demonstrating potent activity against multidrug-resistant pneumonia bacteria in mice models.

Patrys Limited has expanded its clinical pipeline by acquiring Reliis Pty Ltd, gaining a proprietary injectable formulation of Quetiapine aimed at the large and underserved delirium market. This strategic move balances Patrys’ portfolio with a near-term pharmaceutical asset alongside its biologics program.

Clarity Pharmaceuticals has raised $203 million to accelerate its copper-64 and copper-67 radiopharmaceutical pipeline, targeting prostate and neuroendocrine cancers with multiple FDA Fast Track trials underway.

Acrux Ltd reported a remarkable surge in licensing revenue from its topical generics portfolio alongside a strategic pivot towards innovative drug delivery R&D at its 2025 Annual General Meeting.

Black Dragon Gold has completed a €2.64 million placement to Spanish high-net-worth investors, strengthening local ties and funding key engineering work for its Salave Gold Project in Asturias.