Stemline Therapeutics’ SL-401 was granted orphan drug designation by the FDA; it is a drug candidate for the treatment of acute myeloid leukemia (AML). SL-401 has completed a multicenter Phase 1/2 clinical trial where it has demonstrated single-agent efficacy, including two durable complete responses, multiple blast reductions and disease stabilizations, and an overall survival benefit in heavily pretreated patients. SL-401 was well tolerated and bone-marrow sparing. SL-401 is now poised for Phase 3 clinical trials in patients with advanced AML.

SL-401 is biologic conjugate that targets the interleukin-3 (IL-3) receptor. 

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