Ryvu Therapeutics S.A. announced that the U.S. Food and Drug Administration, FDA, has placed a partial clinical hold on the first in human phase Ib, dose escalation clinical trial of RVU120 (also known as SEL120) in patients with relapsed/refractory (R/R) AML and high-risk MDS, being conducted in the United States. Patients who are currently taking RVU120 may continue treatment in the study. No new patients may be enrolled in the study until the partial clinical hold is lifted by the FDA. Ryvu received the clinical hold letter from the FDA on April 8th and plans to work diligently with the agency to address the comments and request, in order to resolve the partial clinical hold. The partial clinical hold was initiated following Ryvu's recent report to the FDA of a Serious Adverse Event involving a patient death that may possibly be related to RVU120. One of the two patients enrolled in Cohort 5, 110 mg dose level, of RVU120 experienced a fatal incidence of "Worsening Pancreatitis. The other patient in the same study cohort, completed the 1st treatment cycle without any serious adverse events (SAE) reported by the investigational site and entered Cycle 2. There are currently two patients continuing to receive treatment with RVU120 in the study.