2023-06-23 12:58:20 ET
Amylix ( NASDAQ: AMLX ) said that an European Medicines Agency advisory committee has given a negative opinion on the EU market application for its drug AMX0035 in the treatment of ALS.
The biotech company said that it believes the drug's clinical trial data is strong and intends to request a formal re-examination of the application. A re-examination would take around four months, it added.
AMX005 is already on the market in the US under the brand name Relyvrio. It's also conditionally approved in Canada, where it is sold under the name Albrioza.
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EMA panel gives negative opinion on Amylix ALS drug application