Swedish oncology-focused development company Vivesto AB (STO:VIVE) said on Tuesday that it has received Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA) for Cantrixil as a treatment for acute myeloid leukemia (AML), marking a regulatory milestone in the drug candidate's development.

This designation provides access to potential development incentives, including tax credits for qualifying clinical trials and exemptions from certain regulatory fees. Cantrixil could also qualify for seven years of US market exclusivity if it receives marketing approval and meets applicable requirements.

Cantrixil is currently in preclinical development for AML, with previous studies demonstrating anti-cancer activity both as a standalone treatment and in combination with established cancer therapies. A Phase I study of Cantrixil has also previously been conducted.

Vivesto said the designation, together with the preclinical findings and previous clinical results, strengthens the basis for advancing Cantrixil toward a Phase I study in AML. The company emphasised that orphan drug status does not constitute marketing approval or establish the drug candidate's safety or efficacy in AML.