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Pharma & Biotech

Clinuvel shares rise as company begins preclinical study of controlled-release injectable platform

Clinuvel Pharmaceuticals (ASX:CUV) shares rose 5.7% after the company began dosing in a new preclinical study evaluating its controlled-release liquid injectable peptide platform, VLRX-L.

The study will assess the safety and kinetics of VLRX-L candidates, with a focus on measuring the controlled-release profile and testing whether drug release can be reproduced using an in-vitro model.

The VLRX-L platform is designed to control the release of peptides — including Clinuvel’s melanocortin-based drugs — through a flexible liquid-dose injectable formulation.

VLRX-L is the first novel pharmaceutical platform to enter its preclinical program from work underway at the company’s Research, Development & Innovation (RD&I) Centre at VALLAURIX in Singapore, which it said has been established following more than a decade of research into peptides, polymers and controlled-release delivery systems.

“Through extensive preliminary work and iterative innovation we have arrived at a VLRX-L candidate platform that has demonstrated encouraging, reproduceable results in-vitro,” said Dr Dennis Wright, CLINUVEL’s Chief Scientific Officer. “The platform now needs to be challenged in in-vivo models to understand how it may ultimately deliver therapies for patients.

“If these initial results are successful in 2026, we will look at the optimal pathways to scale up and commercialise this technology, with a view to extensively expanding our pipeline with our own IP.

“Long-term, the goal is to establish a suite of delivery platforms for melanocortins, and other peptides, which meet the diverse needs of a range of patient groups, addressing some of the challenges currently offered on the market. It is exciting that we can now start to unveil the work of our VALLAURIX team and our ambitions for the next generation of CLINUVEL’s products.”

Program to be complete in H226

The company is advancing a range of platform approaches at the Singapore centre and is targeting completion of the preclinical program in the second half of 2026, when results from the VLRX-L platform evaluation are expected.

In December 2025, Clinuvel announced an expansion of its VALLAURIX RD&I Centre focused on injectable controlled-release formulations. The company said the 5-year investment plan, supported by the Singapore Economic Development Board, will increase headcount and add new facilities aimed at broadening formulation and analytical capabilities.

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