On March 3, 2025 4SC AG ("4SC") (Frankfurt Stock Exchange, Prime Standard: VSC; ISIN: DE000A3E5C40) reported that it was informed by the European Medicines Agency (EMA) based on its review of the final data and the Company’s responses to questions, the application for resminostat (Kinselby) an orphan medicinal product for the treatment of patients with CTCL is currently not approvable since "major objections" preclude a recommendation for marketing authorisation at this stage (Day-180 Assessment Report) (Press release, 4SC, MAR 3, 2025, View Source [SID1234650847]).

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4SC will now evaluate the feedback and decide how best to respond to EMA’s objections and list of outstanding issues in line with the given response deadline of one month.