CHMP rejects Kinselby

As already expected and announced 4SC AG (received a Negative Opinion on the Company’s Market Authorization Application for Resminostat (Kinselby) for the treatment of patients with advanced stage cutaneous T-cell lymphoma (CTCL) from the Committee for Medicinal Products for Human Use (CHMP) of the EMA. Following an Oral Explanation on 20 May 2025 and the CHMP’s review of the data on quality, safety and efficacy for Resminostat (Kinselby) in the treatment of patients with advanced stage mycosis fungoides (MF) and Sézary syndrome (SS) that have achieved at least stable disease with at least one prior systemic therapy or Total Skin Electron Beam therapy (TSEB) – the CHMP considers by consensus that the efficacy of the above-mentioned medicinal product is not sufficiently demonstrated, and therefore, recommends the refusal of the granting of the marketing authorisation for Resminostat (Kinselby).

Dr. Jason Loveridge, CEO of 4SC, commented: “We had hoped that the long wait for a maintenance treatment to help manage CTCL would soon be over. We are therefore deeply disappointed with this outcome as it is a further setback for people living with this rare and incurable disease.”

As already communicated on 20 May 2025, 4SC will thus cease all efforts to develop and commercialize Resminostat (Kinselby). Currently, 4SC has at least a 12-month cash runway to finance the Company’s projected expenses as the Management and Supervisory Boards consider all options for the Company, including liquidation.