Latest Regulatory Pathways News

Neurotech International has reported positive human pharmacokinetic results for NTI164, a cannabinoid formulation designed for paediatric neurological disorders, confirming rapid absorption and a non-intoxicating profile.

EVE Health Group has initiated stability testing for its novel oral treatments targeting erectile dysfunction and dysmenorrhea, marking a crucial step toward regulatory approval in Australia. The company also finalizes its acquisition of Nextract, the developer behind these innovative formulations.

Archer Materials has achieved a significant milestone by integrating its graphene-based sensors with silicon readout circuitry, paving the way for a compact, at-home potassium testing device aimed at chronic kidney disease management.

Neuren Pharmaceuticals posted record 2024 financials driven by DAYBUE royalties and advanced NNZ-2591 into Phase 3 trials, while launching a $50 million share buy-back amid volatile market sentiment.

Neuren Pharmaceuticals has approved a significant long-term equity incentive plan tied to critical clinical and regulatory milestones for its drug candidate NNZ-2591, reinforcing management’s commitment to shareholder value.

Estrella Resources has entered a landmark Master Agreement with Indonesian firm PT Raka Energi Mandiri, granting exclusive rights to market and purchase limestone from Timor-Leste, targeting sales of up to 500 million tonnes over five years.

Island Pharmaceuticals has raised $3.6 million through a strategic share placement to advance its lead antiviral drug ISLA-101’s clinical development and broaden its asset portfolio ahead of pivotal Phase 2a/b trial results.

EMVision Medical Devices has enhanced its AI-powered stroke diagnostic algorithm, achieving a notable 95% sensitivity and 80% specificity in recent tests. This progress sets the stage for upcoming pivotal trials and regulatory milestones.

Cleo Diagnostics has completed alpha testing of its ovarian cancer pre-surgical triage assay kits, confirming robust performance and differentiation between benign and malignant disease. The company now moves forward to assay optimisation and manufacturing scale-up, edging closer to FDA submission and commercial launch.

Cardiex Limited has formally lodged its CONNEQT Pulse device with Australia's Therapeutics Goods Administration, marking a critical step toward regulatory approval and market expansion.

Bio-Gene Technology Limited is progressing its development of two novel insecticidal compounds, Qcide and Flavocide, targeting major global markets with strong commercial validation and significant US Department of Defense funding.

Immutep’s combination of eftilagimod alfa (efti) and KEYTRUDA® delivers a striking 17.6-month median overall survival in head and neck cancer patients with low PD-L1 expression, a group with limited treatment options.