4SC updates on Kinselby marketing application

German clinical-stage biotech 4SC AG (4SC: FSE) today announced that it has submitted its responses to the Day-120 List of Questions from the European Medicines Agency (EMA) in December 2024 as planned, following 4SC’s initial Marketing Authorization Application (MAA) filing for resminostat (trade name Kinselby) in March 2024.

4SC noted that the EMA has notified 4SC that its responses have been accepted as complete and that examination of the company’s MAA shall continue according to schedule.

The Day-120 List of Questions were issued by the Committee for Medicinal Products for Human Use (CHMP) as part of the centralized review process for resminostat, an orally available treatment for cutaneous T-cell lymphoma (CTCL).

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