Latest Regulatory Pathways News

Dimerix has strengthened its kidney disease pipeline with a US patent grant for DMX-652, extending protection until 2043 and setting the stage for a Phase 2 trial targeting acute kidney injury after cardiac surgery.

PYC Therapeutics has secured Safety Review Committee approval to escalate dosing in its Phase 1b trial of PYC-003 for Polycystic Kidney Disease, alongside regulatory clearance for an Open-Label Extension allowing continuous dosing up to 24 months.

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.

Biotron has received pivotal regulatory feedback from the European Medicines Agency ruling out a Hybrid Marketing Authorisation for SedRx, prompting plans for pivotal clinical trials. The company also advances its lead antiviral candidate BIT-HBV001 against Hepatitis Delta Virus and appoints a new chairman.

Energy Transition Minerals (ASX:ETM) has completed its purchase of the Penouta Tin-Tantalum-Niobium mine in Spain, advancing its ambition to become a key European critical minerals producer with plans to restart operations.

Resolution Minerals has earned FAST-41 transparency status for its Golden Gate Project in Idaho, marking its second such designation and positioning the company as a key player in U.S. critical minerals supply chain development.

Neurizon Therapeutics has completed enrolment for Regimen I of its HEALEY ALS Platform Trial in under five months, speeding up topline data release to late Q2 2027 and materially de-risking its lead clinical program.

Ausgold Limited has cleared significant regulatory hurdles for its Katanning Gold Project, with Western Australia’s EPA approving the Environmental Review Document for public release and three new mining leases granted, paving the way for a final investment decision by late 2026.

Mesoblast has completed treatment of 300 patients in its pivotal Phase 3 trial for rexlemestrocel-L, targeting chronic low back pain due to degenerative disc disease, with topline results expected mid-2027.

INOVIQ Ltd has revealed significant sample quality problems in its EXO-OC ovarian cancer diagnostic study, prompting a technical review and a refined development approach while maintaining its dual commercialisation strategy.

Neurotech International has secured FDA clearance for its Investigational New Drug application for NTI164, enabling clinical development in the US and advancing its global registration and commercialisation plans.

Biotron Limited has met the first milestone in its Sedarex acquisition by securing pivotal regulatory feedback from the European Medicines Agency, charting a clearer path for its next-generation anaesthetic SedRx.