Stemline AML Drug Gains Orphan Status

Stemline Therapeutics’ lead compound SL-401, has received Orphan Drug designation from FDA for the treatment of acute myeloid leukemia (AML).

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Stemline Therapeutics’ lead compound SL-401 has received Orphan Drug designation from FDA for the treatment of acute myeloid leukemia (AML). The orphan designation helps to support the development of new therapies that treat rare diseases and offers incentives such as seven years of marketing exclusivity, tax credits, and clinical development grants, as well as a waiver of Prescription Drug User Fee Act (PDUFA) filing fees. SL-401 has completed a multi-center Phase I/II trial in AML demonstra...

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