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.
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.
Get Boston local news, weather forecasts, lifestyle and entertainment stories to your inbox. Sign up for NBC Boston’s newsletters.
