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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

Praxis Precision Medicines(PRAX) 0
高盛(GS) 0

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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