Amylyx Pharmaceuticals Inc. (AMLYX, -4.60%) shares fell 7.5% premarket on Friday after the company announced that the European Medicines Agency had upheld its negative opinion on Albrioza, a treatment for amyotrophic lateral sclerosis (ALS). The decision comes after a re-examination of the initial negative opinion issued in June.
Delay in European Approval
While Albrioza was granted full approval by the U.S. Food and Drug Administration under the brand name Relyvrio over a year ago, its path to approval in Europe has hit a roadblock. The European ALS community, which is in urgent need of new and effective treatment options, feels frustrated by this delay.
Amylyx’s Commitment to ALS Patients
Stephanie Hoffman-Gendebien, Amylyx’s General Manager and Head of EMEA, expressed the company’s shared frustration with the European ALS community. She stated that Amylyx remains committed to exploring alternative avenues to expedite the availability of Albrioza to ALS patients in the European Union.
As a result of this setback, Amylyx shares have declined by 52% year to date. It is noteworthy that during the same period, the S&P 500 has recorded a gain of 13.3% (SPX, -0.62%).