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Ryvu Therapeutics receives Orphan Drug Designation from FDA

Current TAP Partner


Krakow, Poland – 28 March 2020 – Ryvu Therapeutics (WSE: RVU), a clinical-stage biopharmaceutical company developing novel small molecule therapies that address emerging targets in oncology, today announced that the U.S. Food and Drug Administration (FDA) has granted an orphan drug designation (ODD) to Ryvu’s SEL120, for the treatment of patients with acute myeloid leukemia (AML).

SEL120 is an oral, selective inhibitor of CDK8 kinase which is implicated in the development of hematological malignancies and solid tumors. A clinical phase 1b study of SEL120 is currently enrolling in 6 investigational sites in USA, investigating safety and preliminary efficacy of SEL120 in treatment of patients with relapsed or refractory AML or high-risk myelodysplastic syndrome (HR-MDS).

The Leukemia & Lymphoma Society (LLS) is a proud partner of Selvita and is providing up to $3.25 million in co-funding over four years, through its Therapy Acceleration Program® (TAP), in order to complete SEL120 IND-enabling studies and a phase I trial in AML.