Amylyx announced that the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency, or EMA, confirmed its initial negative opinion on the Marketing Authorization Application, or MAA, for AMX0035, under the trade name Albrioza, for the treatment of amyotrophic lateral sclerosis, or ALS, in the European Union, or EU. The decision follows the conclusion of the CHMP’s formal re-examination procedure of an initial negative opinion adopted in June.
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