Ariceum receives Orphan Drug Designation from FDA for ‘theranostic pair’

Ariceum Therapeutics has secured Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for actinium-225 (Ac-225) SSO110 for the treatment of small-cell lung cancer.

The designation provides development and commercial incentives, including eligibility for seven years of market exclusivity in the U.S. after product approval, FDA assistance in clinical trial design, and an exemption from FDA user fees, the company noted.

Ac-225 SSO110 (satoreotide) and a companion PET radiotracer gallium-68 SSO110 are under development as a “theranostic pair” for the combined diagnosis and targeted radionuclide treatment of multiple aggressive, hard-to-treat cancers, with the launch of a phase I/II clinical trial expected in the first quarter of 2025, the company said.