On May 20, 2025 The Management Board of 4SC AG ("4SC") (Frankfurt Stock Exchange, Prime Standard: VSC; ISIN: DE000A3E5C40) reported by representatives of the European Medicines Agency (EMA) that a negative recommendation from the Committee for Medicinal Products for Human Use (CHMP) on the Marketing Authorisation Application (MAA) for resminostat (Kinselby) for the treatment of patients with advanced cutaneous T-cell lymphoma (CTCL) is expected on May 22, 2025 (Press release, 4SC, MAY 20, 2025, View Source [SID1234653253]).

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The information that a negative recommendation is to be expected comes despite 4SC’s extensive efforts to resolve the EMA’s last remaining significant objection regarding the demonstration of a positive benefit-risk balance for patients with advanced cutaneous T-cell lymphoma, most recently in an oral discussion today.

Therefore, 4SC is now discontinuing further development and commercialization of resminostat (Kinselby). 4SC’s Management Board will discuss the company’s future direction with the Supervisory Board in a timely manner and will inform shareholders as soon as possible. 4SC has sufficient financial resources to finance the company’s currently planned expenditures for at least 12 months.