The European Medicines Agency (EMA) has swatted away Minoryx Therapeutics’ attempt to bring a rare disease drug candidate to market on the strength of a clinical trial that missed its primary endpoint. But, undeterred, Minoryx and partner Neuraxpharm are seeking a re-examination of the regulatory rejection.
The US Food and Drug Administration (FDA) has granted clearance to Minoryx Therapeutics to initiate a Phase III clinical trial of leriglitazone to treat adult male X-linked adrenoleukodystrophy (X-ALD) patients with cerebral adrenoleukodystrophy (cALD).
Minoryx Therapeutics and the Neuraxpharm Group enter into a license agreement for the European rights to leriglitazone, which is currently under EMA review for the orphan indication X-linked Adrenoleukodystrophy (X-ALD).
Mataró, Barcelona, Spain, September 14, 2022 - Minoryx Therapeutics, a late-stage biotech company focused on the development of treatments for orphan central nervous system (CNS) disorders, today announces that it has filed a Marketing Authorization Application (MAA) for its lead candidate leriglitazone to the European Medicines Agency (EMA) for the treatment of adult male patients with X-linked adrenoleukodystrophy (X-ALD). The EMA has now validated the MAA file and it is under review by the Committee for Medicinal Products for Human Use (CHMP).
Minoryx has persuaded investors to overlook the failure of its phase 2/3 clinical trial, enabling it to reel in 51 million euros ($55 million) to support attempts to bring the rare disease drug to market in Europe and the U.S.
Mataró, Barcelona, Spain, January 26, 2021 - Minoryx Therapeutics, a Phase 3 clinical stage biotech company focused on the development of differentiating treatment options in orphan central nervous system (CNS) disorders, today announces topline results from its Phase 2/3 ADVANCE clinical trial. The study evaluated leriglitazone, a novel, selective PPAR? agonist, in male patients with adrenomyeloneuropathy (AMN), a neurodegenerative disease causing progressive spastic paraparesis and autonomic nervous system dysfunction. Additionally, AMN patients are at risk of developing progressive cerebral lesions, a devastating form of the disease leading to rapid severe disability and fatal if left untreated.
The European Investment Bank (EIB) today announced that it has approved €25 million financing for Minoryx Therapeutics, a Phase 3 clinical stage biotech company focused on the development of differentiating treatment options for orphan central nervous system (CNS) disorders.
HONG KONG and BEIJING and BARCELONA, Spain, Sept. 23, 2020 /PRNewswire/ -- Sperogenix Therapeutics, a platform company dedicated to developing and commercializing rare disease therapeutics in China, and Minoryx Therapeutics, a company that specializes in the development of innovative treatments for orphan Central Nervous System (CNS) diseases, today announce that they have entered into an exclusive license agreement for the development and commercialization of leriglitazone, Minoryx's brain penetrating disease-modifying PPAR-? agonist.
Mataró, Barcelona, Spain and Charleroi, Belgium, May 12, 2020 – Minoryx Therapeutics, a company that specializes in the development of innovative treatments for orphan Central Nervous System (CNS) diseases, today announces the initiation of the registration-enabling Phase 2 NEXUS trial to evaluate the safety and efficacy of leriglitazone in pediatric patients with early-stage cerebral ALD (cALD), the acute form of X-linked adrenoleukodystrophy (X-ALD).
Minoryx Therapeutics a company specializing in the development of new drugs for orphan diseases, today announces that it has received approval from the Spanish Agency of Medicines and Medical Devices (AEMPS) to launch a phase 2 clinical trial in Friedreich’s Ataxia with its lead candidate, MIN-102.