Shots:
- EC has approved Nezglyal (leriglitazone) under exceptional circumstances for male cALD pts (2-12yrs.) with Gadolinium (Gd)-negative brain lesions, based on P-II/III (NEXUS) trial data & RWE data from compassionate use programs
- The first EU launch is expected in Germany by year-end, with additional launches anticipated following national reimbursement negotiations, while Neuraxpharm evaluates access pathways for eligible pts
- Nezglyal is being further assessed in the P-III (CALYX) trial in adult male cALD pts with Gd-enhancing lesions, & the ongoing P-IIa (TREE) trial in paediatric pts with Rett syndrome; read-outs are expected in early 2028 & by the end of 2026, respectively
Ref: Businesswire | Image: Neuraxpharm & Minoryx | Press Release
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