Amylyx Pharmaceuticals Inc. has won its first approval from the U.S. Food and Drug Administration for a drug designed to treat amyotrophic lateral sclerosis, or ALS.
The news came after market close on Thursday. The Cambridge company's shares were up about 11% in after-hours trading as of 7 p.m.
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The company closed the day Thursday with a market capitalization of nearly $1.8 billion.
The approval was largely expected ever since a key advisory committee to the FDA voted 7-2 in favor of the drug earlier this month. But that vote came with a caveat: At the beginning of the committee's meeting, the FDA's Billy Dunn prompted Amylyx's leaders to promise that they would pull the drug from the market if it failed in a confirmatory trial. Company leaders complied, but Dunn and his colleagues repeatedly asserted that the agency had legal authority to revoke an approval if that happens.
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