Amylyx says FDA decision date for ALS therapy is now in September; shares jump

Shares of Amylyx Pharmaceuticals Inc. Inc. soared 21.6% in premarket trading on Friday after the company said U.S. regulators extended the review time for its experimental amyotrophic lateral sclerosis treatment. The new Prescription Drug User Fee Act date is Sept. 29. Amylyx’s stock is down 62.4% over the last three months, while the S&P 500 has declined 4.8%.

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