Shattuck Labs announces ODD granted by FDA for SL-172154

Shattuck Labs announced that the U.S. FDA has granted orphan drug designation, ODD, to lead clinical candidate SL-172154 for the treatment of AML. “AML patients have few options for treatment and a poor prognosis. FDA’s decision to grant orphan drug designation to SL-172154 highlights the urgent need for new treatment options,” said Taylor Schreiber, M.D., Ph.D., Chief Executive Officer of Shattuck. “This is an important first step in our progression to later-stage clinical studies, and we look forward to presenting additional data from the Phase 1B dose expansion clinical trial of SL-172154 with azacitidine in frontline higher-risk myelodysplastic syndromes and TP53m AML patients during a poster presentation at the European Hematology Association 2024 Congress.”