Receives ODD for Cantrixil in the US

The FDA has granted Cantrixil ODD in AML, which we believe further supports advancement of the programme into clinical studies. However, Vivesto does not currently appear to have the resources to progress the asset independently and is instead pursuing partnering opportunities across its human and veterinary programmes. Despite positive Paccal Vet data reported during the autumn, the share price has remained weak, reflecting a still-challenging market environment for Swedish micro-cap companies, particularly for biotechs.

What’s new? The US Food and Drug Administration (FDA) has granted Cantrixil Orphan Drug Designation (ODD) for the treatment of acute myeloid leukaemia (AML), an aggressive blood cancer with substantial unmet need, particularly in relapsed or refractory disease. Although the candidate remains in preclinical development, it has demonstrated promising efficacy in AML models, alongside encouraging pharmacokinetic and safety data.

What does it mean? Securing ODD is important, we believe, as it provides access to potential development incentives and, if approved in the US, seven years of market exclusivity.

What do we do? We believe the promising preclinical data and ODD further support Cantrixil’s progression towards Phase I development, potentially as early as next year. However, clinical development is likely to be costly and, in our view, would ideally be pursued with a partner. We also believe the designation should strengthen the programme’s appeal in partnering discussions.