Latest Clinical Development News

Radiopharm Theranostics has bolstered its cash position with an $8 million placement from Lantheus Holdings, now its largest shareholder. New clinical data highlight promising advances in brain metastases detection and HER2-targeted radiopharmaceutical therapies.

Immutep Limited has dosed the first patient in its pivotal Phase III lung cancer trial and completed enrolments in multiple studies, supported by a robust cash position expected to fund operations through 2026.

Race Oncology has opened a second Australian clinical site for its Phase 1 trial of RC220 combined with doxorubicin in advanced solid tumours, aiming to speed patient enrolment and gather critical safety and efficacy data.

Zelira Therapeutics has received a $1.15 million cash refund from the Australian Government’s R&D Tax Incentive Scheme, bolstering its working capital to advance clinical development and business operations.

Opthea has completed the final patient visit in its pivotal COAST Phase 3 trial evaluating sozinibercept combined with aflibercept for wet AMD, with topline results expected early Q2 2025.

PYC Therapeutics has launched a A$145.8 million pro-rata accelerated non-renounceable entitlement offer to fund late-stage clinical trials across its pipeline targeting rare diseases with high unmet needs. The capital raise aims to extend the company’s cash runway beyond FY27, supporting four drug candidates through critical human safety and efficacy milestones.

PYC Therapeutics is set to raise up to $146 million through a pro-rata entitlement offer, aiming to accelerate its RNA-based drug candidates targeting major unmet medical needs. Major shareholder support and underwriting commitments underpin the capital raise.

Neurizon Therapeutics received FDA guidance on its IND application for NUZ-001, with a single request for additional animal exposure data but no safety concerns flagged. The company is actively addressing the FDA’s request while evaluating impacts on its ALS trial timeline.

Avecho Biotechnology has responded to an ASX price query, confirming no undisclosed information exists to explain recent trading spikes, while highlighting market speculation linked to its Phase III CBD insomnia trial.

EMVision Medical Devices has secured US ethics approval for its pivotal multi-centre trial of the EMVision emu™ brain scanner, paving the way for a March 2025 trial start aimed at FDA clearance.

Clarity Pharmaceuticals has expanded its breast cancer pipeline by introducing 64/67Cu-SAR-trastuzumab, supported by promising pre-clinical data and a new supply agreement for trastuzumab, aiming to address the unmet needs in HER2-positive breast cancer treatment.

Alterity Therapeutics has raised A$40 million through a two-tranche placement to advance its lead compound ATH434 for neurodegenerative diseases, including Multiple System Atrophy and Parkinson's disease.