EMA Awards PRIME Status to Pentixapharm's Ga68-PentixaFor

On October 18, 2024, Pentixapharm Holding AG announced that the European Medicine Agency (EMA) has granted PRIME status to its lead candidate Ga68-PentixaFor. This recognition offers early and proactive development support as well as the possibility of accelerated approval for this novel radiodiagnostic tracer. The EMA's PRIME status is reserved for promising medicines addressing unmet medical needs, providing tailored guidance to accelerate their path to market.

Ga68-PentixaFor is designed for positron emission tomography (PET) imaging, targeting the C-X-C receptor 4 (CXCR4). It offers a potential non-invasive alternative to the currently invasive and complex adrenal venous sampling (AVS) for diagnosing primary aldosteronism (PA), an adrenal gland disorder leading to secondary hypertension.

Pentixapharm is set to commence a Phase III pivotal study for Ga68-PentixaFor in 2025, aiming to achieve marketing authorization for PA treatment. The PRIME status enhances interaction with the EMA, facilitating iterative scientific advice and potentially expedited assessments.