Tag Archive for: EMA

European Commission grants marketing authorisation for NEZGLYAL® (leriglitazone), the first pharmacological treatment approved for cerebral Adrenoleukodystrophy (cALD), a rare neurodegenerative disease

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Approval is based on NEXUS data and follows positive CHMP opinion in July; first European launch is expected by end of 2026 Barcelona, Spain and Düsseldorf, Germany – 25 September, 2026 – Neuraxpharm Group and Minoryx Therapeutics, today announce that the European Commission (EC) has granted marketing authorisation under exceptional circumstances for NEZGLYAL® (leriglitazone), an […]

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NEZGLYAL® (leriglitazone) receives a positive CHMP opinion for the treatment of cerebral Adrenoleukodystrophy (cALD), a rare neurodegenerative disease

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Recommendation based on NEXUS data; Minoryx and Neuraxpharm expect European Commission approval by the end of this quarter Barcelona, Spain and Düsseldorf, Germany – 24 July, 2026 – Minoryx Therapeutics and Neuraxpharm Group, announce that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended granting marketing authorisation approval under exceptional […]

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Leriglitazone Marketing Authorization Application submitted for treatment of cerebral adrenoleukodystrophy has been validated by European Medicines Agency

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Barcelona, Spain and Düsseldorf, Germany – 23 July 2025 – Minoryx Therapeutics, a late-stage biotech company focused on the development of therapies for orphan central nervous system (CNS) disorders and Neuraxpharm Group (Neuraxpharm), a leading European specialty pharmaceutical company focused on the treatment of CNS disorders, today announce that the Marketing Authorization Application (MAA) for Minoryx’s […]

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

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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 […]

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Update on Regulatory Review of leriglitazone in the EU

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A re-examination for cerebral adrenoleukodystrophy (cALD) will be requested following a negative CHMP opinion Barcelona, Spain and Düsseldorf, Germany – 26 January, 2024 – Minoryx Therapeutics, a late stage biotech company focused on the development of therapies for orphan central nervous system (CNS) disorders and Neuraxpharm Group (Neuraxpharm), a leading European specialty pharmaceutical company focused […]

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