FDA Grants Orphan Drug Designation to Cardiff Oncology’s Onvansertib for CMML

Key Facts

1The U.S. FDA granted Orphan Drug Designation to Cardiff Oncology's onvansertib for the treatment of chronic myelomonocytic leukemia (CMML).

The U.S. FDA granted Orphan Drug Designation to Cardiff Oncology's onvansertib for the treatment of chronic myelomonocytic leukemia (CMML). GlobeNewswire reported that the designation is intended to support the development of therapies for rare diseases affecting fewer than 200,000 people in the U.S., particularly as 40-50% of CMML patients harbor RAS-pathway mutations associated with aggressive disease.

CRDF closed at $0.9315 on October 20, 2026, after trading between a day low of $0.88 and a high of $0.98. This regulatory milestone for the clinical-stage biotech company provides incentives including market exclusivity and tax credits, building on preliminary efficacy data previously demonstrated by the drug candidate in treating hematologic malignancies.