U.S. FDA to reconvene experts’ meeting for Amylyx ALS drug
July 5 (Reuters) – Amylyx Pharmaceuticals (AMLX.O) said on Tuesday the U.S. Food and Drug Administration (FDA) will reconvene a meeting of its outside experts to review the company’s application seeking approval for its amyotrophic lateral sclerosis (ALS) treatment.
A panel of outside advisers to the U.S. FDA in March voted six to four against its oral drug, AMX0035, saying the company’s clinical study data failed to establish it was effective against ALS. read more
Shares of the company, which said the next meeting on Sept. 7 will focus on additional analyses from its clinical studies, jumped nearly 10% to $21.41 before the bell.
ALS, whose cause is largely unknown, leads nerve cells in the brain and spinal cord to break down, affecting physical function, resulting in severe disability and even death.
FDA’s decision on the drug, which was approved in Canada in June, is expected by Sept. 29. read more
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