Latest Clinical Development News

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.

Paradigm Biopharmaceuticals has strengthened its balance sheet with a combined $5.75 million cash inflow from Australian Government R&D tax incentives, supporting its pivotal Phase 3 osteoarthritis trial and regulatory efforts.

Actinogen Medical’s phase 2 trial of Xanamem in major depressive disorder with cognitive impairment reveals meaningful antidepressant effects, published in the British Journal of Psychiatry. The drug was safe and well-tolerated but did not improve cognition.

Starpharma Holdings is raising approximately $32 million through a fully underwritten 1-for-7.5 renounceable entitlement offer priced at $0.57 per share, discounting the stock by 25%. Proceeds will fund the DEP HER2-Lu Phase 1 trial and expand its dendrimer-based oncology pipeline.

Dimerix has acquired DMX-652, a Phase 2-ready oral drug candidate targeting acute kidney injury, expanding its renal disease portfolio. The acquisition includes patent rights, an FDA-approved trial protocol, and funding to initiate clinical development.

TrivarX has locked in investigational product supply critical for starting its Phase 1 clinical trial of the Stabl-Im MRI imaging platform, targeting a 2026 trial commencement.

Neurotech International has locked in a $3.15 million secured loan against its anticipated R&D tax incentives to fund pivotal Phase III autism trials and ongoing operations.

Starpharma launches a fully underwritten $32 million entitlement offer to fund the Phase 1 trial of its DEP® HER2-Lutetium radiopharmaceutical and accelerate its targeted oncology asset development.

Nexalis Therapeutics has issued share rights to directors in lieu of fees, with vesting contingent on successful Phase 2 clinical trial completion, aiming to conserve cash for ongoing drug development.

Recce Pharmaceuticals has expanded its intellectual property footprint with a key patent granted in Vietnam for its RECCE® anti-infective drugs, reinforcing its presence in a critical Southeast Asian market grappling with high antibiotic resistance.

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.