Race Oncology said the US Food and Drug Administration has granted orphan drug designation to its re-formulated RC220 bisantrene drug for the treatment of acute myeloid leukemia.

The designation status provides Race Oncology with several benefits, including seven years of market exclusivity in the US, tax credits, fee waivers, and eligibility for research grants from the FDA.

The original ODD for bisantrene was first granted to Update Pharma in 2014 and was transferred to Race in 2017.

"Orphan Drug Designation is a major asset beyond AML as it enables Race to work closely and constructively with the FDA on all of our RC220 bisantrene clinical programs as we progress towards opening an FDA IND in 2025," said Michelle Rashford, Race Oncology's chief medical officer.