On June 19, 2023 4SC AG (4SC, FSE Prime Standard: VSC) reported that the European Medicines Agency (EMA) has notified 4SC that it has accepted its Letter of Intent to Submit a MAA and has informed 4SC that its nominated trade name for resminostat – Kinselby – has been accepted by its Name Review Group (NRG) (Press release, 4SC, JUN 19, 2023, View Source [SID1234632780]).

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If approved by regulatory authorities, Kinselby (resminostat) would be the first HDAC inhibitor approved in Europe for CTCL and the first and only drug approved for maintenance therapy in this disease, making it the Company’s most valuable asset. The positive outcome to RESMAIN creates an opportunity to either sell, license or partner 4SC’s resminostat program for commercialization worldwide (excluding Japan), where Yakult Honsha Co. Ltd, was granted an exclusive license for the development and marketing of resminostat in Japan in 2011.

Jason Loveridge, CEO of 4SC: "This is another key milestone for 4SC in moving resminostat to market in the EU. Now we have an accepted tradename for resminostat we will continue preparation of our MAA and the commercialisation of Kinselby for the benefit of all stakeholders".