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Controversial ALS Drug From Amylyx Gets Rare Second FDA Meeting

  • Panel votes 7-2 to support approval of the treatment
  • Company’s drug was narrowly rejected by FDA advisers in March
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Amylyx Pharmaceuticals Inc. shares climbed after its controversial treatment for amyotrophic lateral sclerosis won the support of a panel of US regulatory advisers, putting the product on track for likely clearance.

During a rare second panel meeting on Wednesday, the Food and Drug Administration’s peripheral and central nervous system drugs advisory committee voted 7-2 to back approval of the treatment. The stock gained as much as 83% at the New York market open, the most since the biotech began selling shares in January.