Amylyx Pharmaceuticals ( NASDAQ: AMLX ) stock rose ~8% on July 5 after the company said that a panel of the U.S. Food and Drug Administration is expected to meet in September to discuss its amyotrophic lateral sclerosis (ALS) medicine AMX0035.
In June, the FDA extended the review period by three months for Amylyx's new drug application (NDA) for AMX0035 to have more time to review additional analyses of data. An advisory panel of the FDA had voted against the approval of AMX0035 in March noting that data from single-trial & open-label study did not establish that the drug was effective.
The FDA set Sept. 29 as the date by which it expects to make a decision.
The FDA informed Amylyx that the Peripheral and Central Nervous System Drugs Advisory Committee (PCNSDAC) is expected to meet on Sept. 7 to discuss additional analyses of data from the company's clinical studies that were determined by the FDA to constitute a major amendment to the NDA, according to a July 5 press release.
"We are pleased that the members of the advisory panel will review additional analyses from our clinical studies, including recently published analyses, supporting the previously reported functional and overall survival benefit for AMX0035," said said Tammy Sarnelli, global head of Regulatory Affairs, Amylyx ( AMLX ).
ALS is a progressive nervous system disorder affecting the nerve cells in the brain and spinal cord, causing loss of muscle control.
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Amylyx stock rises 8% as FDA panel sets September meeting to discuss ALS drug