European Commission grants marketing authorisation for NEZGLYAL® (leriglitazone), the first pharmacological treatment approved for cerebral Adrenoleukodystrophy (cALD), a rare neurodegenerative disease

Approval is based on NEXUS data and follows positive CHMP opinion in July; first European launch is expected by end of 2026 Barcelona, Spain and Düsseldorf, Germany – 25 September, 2026 – Neuraxpharm Group and Minoryx Therapeutics, today announce that the European Commission (EC) has granted marketing authorisation under exceptional circumstances for NEZGLYAL® (leriglitazone), an…

FDA Grants Breakthrough Therapy Designation to Glycomine’s GLM101 for the Treatment of PMM2-CDG

Designation is based on clinical evidence from Phase 2a, including improvements in ataxia and other clinical measures after 24 weeks of GLM101 treatment Topline data from the randomized, placebo-controlled portion of the global Phase 2b POLAR study expected in the fourth quarter of 2026 SAN CARLOS, Calif., September 23, 2026 – Glycomine, Inc. announced today…

Minoryx and Neuraxpharm complete enrolment in leriglitazone pivotal Phase 3 trial (CALYX) in adult patients with cerebral Adrenoleukodystrophy (cALD)

Top-line results expected in early 2028; trial to support future label expansion in the EU and to enable NDA filing in the US. Mataró, Barcelona, Spain, and Düsseldorf, Germany, 09 September 2026 – Minoryx Therapeutics and Neuraxpharm Group (Neuraxpharm), announce that the last patient has been enrolled in the global Phase 3 clinical trial (CALYX)…