Amylyx receives CHMP negative opinion for AMX0035 ALS approval in EU; will seek re-examination

Amylyx Pharmaceuticals, Inc.

CHMP adopted negative opinion on conditional marketing authorisation for AMX0035 (ALBRIOZA) for ALS in EU.
Company will request formal re-examination, a ~4-month process with new rapporteur and co-rapporteur.
Topline results from global Phase 3 PHOENIX study expected mid-2024.
ALS affects ~30,000 people in Europe; no new ALS innovations approved in EU in over 25 years.
AMX0035 is approved in the U.S. and with conditions in Canada based on CENTAUR trial data.

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