Tag Archive for: EMA

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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Synendos Therapeutics AG Granted EMA Clinical Trial Authorisation for first-in-class Endocannabinoid System modulator, SYT-510

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Synendos Therapeutics transitions to a clinical-stage biotech company developing innovative Endocannabinoid System (ECS) treatments for neuropsychiatric, neuroinflammatory and other Central Nervous System (CNS) disorders Clinical Trial will investigate the safety, tolerability and pharmacokinetics of Synendos’ first-in-class ECS modulator BASEL, Switzerland – 18 January 2024 – Synendos Therapeutics AG (Synendos), a world leader in innovative Endocannabinoid System […]

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4SC provides Q3 highlights and financial forecast

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Planegg-Martinsried, Germany, 19 October 2023 – 4SC AG (4SC or “the Company”) (4SC, FSE Prime Standard: VSC), a biotech company improving the lives of patients suffering with advanced-stage cutaneous T-cell lymphoma (CTCL), today provided a business update for the three months ended 30 September 2023, as well as its current outlook. The full report is available […]

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