U.S. FDA Grants Orphan Drug Designation to Ariceum Therapeutics’ Proprietary Radiopharmaceutical Cancer Therapy
- 225Ac-satoreotide is a first-in-class Actinium-labelled somatostatin receptor 2 antagonist targeting extensive-stage Small Cell Lung Cancer or Merkel Cell Carcinoma
- Orphan Drug Designation follows outstanding preclinical data and FDA IND clearance
- Phase I/II human trials set to commence in Q1 2025 as a ‘theranostic’ targeted radionuclide treatment
Berlin, Germany, 6 February 2025 – Ariceum Therapeutics (Ariceum), a private biotech company developing radiopharmaceutical products for the diagnosis and treatment of certain hard-to-treat cancers, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to 225Ac-SSO110 (satoreotide) for the treatment of patients with Small Cell Lung Cancer (SCLC).
