Amylyx Pharmaceuticals shares fall after ALS treatment is rejected by European regulator

Amylyx Pharmaceuticals Inc.
AMLX,
-4.60%
shares fell 7.5% premarket on Friday after the company said the European Medicines Agency had confirmed its negative opinion on Albrioza, a treatment for amyotrophic lateral sclerosis. The decision comes after a re-examination of the initial negative opinion issued in June. Albrioza was granted full approval by the U.S. Food and Drug Administration, under the brand name Relyvrio, more than a year ago. “We share the frustration felt by the European ALS community, who has no time to wait for new, safe, and effective treatment options,” Stephanie Hoffman-Gendebien, Amylyx general manager and head of EMEA, said in a statement. The company remains committed to “exploring all potential paths forward” to get the treatment to ALS patients in the European Union as quickly as possible, Hoffman-Gendebien said. Amylyx shares are down 52% in the year to date, while the S&P 500
SPX,
-0.62%
has gained 13.3%.