Minoryx’s NEZGLYAL wins positive CHMP opinion for pediatric cerebral adrenoleukodystrophy in EU

Reuters2026/07/27 08:46

By:Reuters

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Minoryx Therapeutics’ NEZGLYAL (leriglitazone) won a positive EMA CHMP opinion for male cALD patients aged 2-12 with Gd-negative brain lesions.
European Commission decision expected by end-September 2026; recommendation supports marketing authorization under exceptional circumstances.
Neuraxpharm is set to commercialize NEZGLYAL in Europe under a license agreement once authorization is granted.
CHMP view based on Phase 2/3 NEXUS results, supported by real-world evidence from compassionate use programs.
Minoryx continues development in CALYX Phase 3 in adult male cALD; TREE Phase 2a in Rett syndrome targets end-2026 readout.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Ysios Capital Partners SGEIC SA published the original content used to generate this news brief on July 27, 2026, and is solely responsible for the information contained therein.

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Minoryx’s NEZGLYAL wins positive CHMP opinion for pediatric cerebral adrenoleukodystrophy in EU

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