On September 26, 2023 4SC AG (4SC, FSE Prime Standard: VSC) reported that it has received notification that US Food and Drug Administration (FDA) has granted 4SC’s application for Orphan Drug Designation for resminostat (Kinselby) for cutaneous T cell lymphoma (CTCL) (Press release, 4SC, SEP 26, 2023, https://www.pressetext.com/news/20230927006 [SID1234635419]).

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Jason Loveridge, Ph.D., CEO of 4SC, commented: "Receiving orphan drug designation for resminostat provides us with a number of important benefits, most crucially 7 years’ market exclusivity in the US, a key foundation of our efforts to commercialise Kinselby. We are currently preparing a marketing authorisation application for Kinselby in the EU, which remains on track for submission in Q1 2024."