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Praxis认为脑病资产瑞卢三嗪行动日期延长

2026-06-30 06:14

  • The US FDA has extended the review period for Praxis Precision Medicines' (PRAX) application for relutrigine for SCN2A and SCN8A developmental and epileptic encephalopathies by three months to Dec. 27.
  • The reason is that the company submitted additional sensitivity analyses of existing data, which the agency considers a "major amendment."
  • No new studies are requested, and no safety or manufacturing issues were mentioned. 

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