(Reuters) – Amylyx Pharmaceuticals Inc said on Tuesday the European drug regulator was likely to reject its amyotrophic lateral sclerosis (ALS) drug, sending its shares down 8.5% in premarket trading.
Amylyx said it was informed that the European Medicines Agency’s committee was “trending toward” a negative opinion on the marketing application for the drug.
The company plans to request a formal re-examination procedure in case of a rejection at the committee’s meeting in June.
The oral drug, branded as Relyvrio in the United States, was approved by the Food and Drug Administration last year for slowing progression of ALS.
The rare neurological disease affects nearly 29,000 people in the U.S. and more than 30,000 people in Europe, according to the company.
(Reporting by Raghav Mahobe in Bengaluru; Editing by Vinay Dwivedi)
