Aktis Oncology Initiates Phase 1B Clinical…

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 lead candidate leriglitazone (NEZGLYAL®) has been submitted to the European Medicines Agency (EMA) for the treatment of paediatric and adult male patients with cerebral adrenoleukodystrophy (cALD). EMA has now validated the MAA file and it is under review by the Committee for Medicinal Products for Human Use (CHMP).

Barcelona, Spain, 17 July 2025 – Minoryx Therapeutics, a late-stage biotech company focused on the development of therapies for orphan central nervous system (CNS) disorders today announces that it has secured a EUR 26.9m non-dilutive grant for the development of its LERI4CNS project, which will validate leriglitazone for treating potentially lethal rare diseases affecting the CNS. The grant was given as part of the pan-European project “Important Project of Common European Interest (‘IPCEI') Med4Cure”, of which Minoryx Therapeutics is an Associated Member.

Barcelona, Spain – 4 March 2025 – Minoryx Therapeutics, a late-stage biotech company focused on the development of therapies for orphan central nervous system (CNS) disorders, today announces that the first patient in the TREE study has been dosed with leriglitazone. TREE is a phase 2a clinical study assessing the safety and efficacy of lead candidate leriglitazone, a novel, brain-penetrant and selective PPAR gamma agonist, to treat patients with Rett syndrome.

Barcelona, Spain and Düsseldorf, Germany – 11 December 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 on the treatment of CNS disorders, today announced that the NEXUS trial has been completed and that the primary endpoint has been met. The parties intend to file for European Marketing Authorization of leriglitazone in pediatric and adult cerebral Adrenoleukodystrophy (cALD) patients by mid-2025.

Mataró, Barcelona, Spain, 11 June, 2024 - Minoryx Therapeutics today announced that results from a compassionate use study of leriglitazone for treatment of progressive cerebral adrenoleukodystrophy (cALD) in adult male patients, published¹ in the peer-reviewed journal Brain.

Mataró, Barcelona, Spain, November 16, 2023 - Minoryx Therapeutics, a registration stage biotech company focused on the development of therapies for orphan central nervous system (CNS) disorders, today announces the first patients have been enrolled in its US Phase 3 clinical trial (CALYX) of lead candidate leriglitazone, to treat adult male X-linked Adrenoleukodystrophy (X-ALD) patients with cerebral Adrenoleukodystrophy (cALD), an orphan indication with no alternative therapeutic options.

Mataró, Barcelona, Spain, May 31, 2023 - Minoryx Therapeutics, a registration stage biotech company focused on the development of therapies for orphan central nervous system (CNS) disorders, today announces the US Food and Drug Administration (FDA) approval of its Phase 3 clinical trial (CALYX) of lead candidate leriglitazone, to treat adult male X-linked Adrenoleukodystrophy (X-ALD) patients with cerebral Adrenoleukodystrophy (cALD).

The CALYX protocol has received both FDA and central IRB approval. Significant preparations for the trial commencement have been completed and patient recruitment is expected to start by the end of Q2 2023 with results anticipated by late 2025.