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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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