Tag Archive for: resminostat

4SC Files Marketing Authorisation Application with EMA for Resminostat (Kinselby)

Planegg-Martinsried, Germany, 1 March 2024 – 4SC AG (4SC, FSE Prime Standard: VSC), a biotech company improving the lives of patients suffering with advanced-stage cutaneous T-cell lymphoma (CTCL), announced today that it has filed its Marketing Authorisation Application (MAA) for resminostat (Kinselby) with the European Medicines Agency (EMA) and that its MAA has been accepted by […]

4SC AG – Company Update

Planegg-Martinsried, Germany, 20 December 2023 – 4SC AG (4SC, FSE Prime Standard: VSC), a biotech company improving the lives of patients suffering with advanced-stage cutaneous T-cell lymphoma (CTCL), announced today that, having incurred a loss amounting to half of its issued share capital, it will convene an Extraordinary General Meeting of shareholders for the 7th February […]

4SC receives Orphan Drug Designation (ODD) for resminostat (Kinselby) in CTCL in the European Union

The European Medicines Agency (EMA) has granted Orphan Drug Designation for resminostat for treatment of cutaneous T-cell lymphoma (CTCL) ODD benefits include 10 years’ market exclusivity in the European Union The Marketing Authorisation Application (MAA) for Kinselby (resminostat) in the EU remains on track for filing in Q1 2024 Planegg-Martinsried, Germany, 18 October 2023 – 4SC […]

4SC receives Orphan Drug Designation (ODD) for resminostat (Kinselby) in CTCL from the US FDA

The US Food and Drug Administration (FDA) has granted 4SC’s application for Orphan Drug Designation for resminostat (Kinselby) for cutaneous T cell lymphoma (CTCL) Marketing Authorisation Application (MAA) for Kinselby (resminostat) in the EU remains on track for filing in Q1 2024 Planegg-Martinsried, Germany, 27 September 2023 – 4SC AG (4SC, FSE Prime Standard: VSC) received notification […]

4SC provides Q2 2023 and H1 2023 update

Positive topline data for resminostat in RESMAIN pivotal study demonstrating 97.6% improvement in progression free survival in CTCL patients and risk reduction of 38% compared to placebo Marketing Authorization Application for resminostat and nominated trade name of Kinselby accepted by EMA Kinselby uniquely positioned as maintenance treatment for CTCL Cash runway to Q3 2024 Planegg-Martinsried, […]