#Nezglyal
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healthcare-global.bsky.social
www.news-medical.net/news/2026092...
European Commission grants marketing authorization for NEZGLYAL® (leriglitazone), the first pharmacological treatment approved for cerebral adrenoleukodystrophy (cALD), a rare neurodegenerative diseas...
Neuraxpharm Group and Minoryx Therapeutics, today announce that the European Commission (EC) has granted marketing authorization under exceptional circumstances for NEZGLYAL® (leriglitazone), an orall...
www.news-medical.net
September 26, 2026 at 7:06 PM
europepharmatoday.bsky.social
Friday: the Commission authorised Nezglyal for early cALD under exceptional circumstances. Four other desk lines are not new EU licences.

https://europepharmatoday.com/pulse/2026-09-25?utm_source=bluesky&utm_medium=social&utm_campaign=pulse-2026-09-25
#EMA
Friday desk card: one EU licence, Nezglyal for early cALD. Exceptional circumstances, boys aged 2 to 12. Four other lines are not marketing authorisations.
September 25, 2026 at 5:38 PM
pharmaphorum.bsky.social
#Neuraxpharm and #MinoryxTherapeutics' #Nezglyal has become the first approved drug therapy in the #EU for rare #neurodegenerativedisease #cerebraladrenoleukodystrophy (cALD), and is set to launch before the end of the year.

pharmaphorum.com/news/eu-clea...
EU clears first drug therapy for rare disease cALD
Neuraxpharm and Minoryx' Nezglyal has become the first approved drug therapy in the EU for rare neurodegenerative disease cALD.
pharmaphorum.com
September 25, 2026 at 1:36 PM
europepharmatoday.bsky.social
Nezglyal (leriglitazone): CHMP positive opinion under exceptional circumstances for boys 2–12 with Gd-negative cALD.
https://europepharmatoday.com/news/chmp-nezglyal-leriglitazone-cald-july-2026?utm_source=bluesky&utm_medium=social&utm_campaign=chmp-nezglyal-leriglitazone-cald-july-2026
#CHMP
July 26, 2026 at 7:54 AM
europepharmatoday.bsky.social
CHMP July catch-up: lipids, Lynavoy, Nezglyal cALD — and three refusals.
Opinion ≠ EU marketing authorisation.
https://europepharmatoday.com/news/chmp-refusals-kemsu-meplyffa-qezzaqar-july-2026?utm_source=bluesky&utm_medium=social&utm_campaign=chmp-refusals-kemsu-meplyffa-qezzaqar-july-2026
#CHMP
July 26, 2026 at 7:54 AM
rubensebas.bsky.social
Very encouraging news from Minoryx, one of my former #biotech portfolio companies

Minoryx is one step closer to achieving approval for leriglitazone (NEZGLYAL) as the only pharmacological treatment for patients suffering from #cALD, a devastating #orphan disease

www.minoryx.com/media/lerigl...
Leriglitazone Marketing Authorization Application submitted for treatment of cerebral adrenoleukodystrophy has been validated by European Medicines Agency
www.minoryx.com
July 23, 2025 at 2:30 PM