Reuters reports the FDA “will reconvene a meeting of its outside experts to review Amylyx Pharmaceuticals’ application for its amyotrophic lateral sclerosis (ALS) treatment, the company said on Tuesday.” In March, the panel of outside advisers “voted six to four against approving the company’s oral drug, AMX0035 [sodium phenylbutyrate/taurursodiol], saying Amylyx’s clinical study data failed to establish it was effective against ALS.” The agency “has since asked for more information from the company and delayed its deadline for deciding on the drug by three months to Sept. 29.”

From the news release of the American Association for Justice.