By Dean Seal
Shares of Amylyx Pharmaceuticals are trading lower after the company said a regulatory body in Europe may issue a negative opinion on its treatment for amyotrophic lateral sclerosis, or ALS.
The stock was down 8.5% at $22.71 in premarket trading.
Amylyx said Tuesday morning that it has been informed the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency is trending toward a negative opinion on a conditional marketing authorization application for AMX0035.
The Cambridge, Mass.-based company said it disagrees with the CHMP’s view and stands behind the data from its trials of the ALS treatment.
If a negative opinion is issued, the company plans to request a formal re-examination procedure, according to Tammy Sarnelli, the global head of regulatory affairs and clinical compliance at Amylyx. A formal re-examination would take about four months.
The CHMP is expected to issue its formal opinion at its next meeting, which is scheduled to be held from June 19 to June 22.
Write to Dean Seal at [email protected]
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