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FDA Extends Praxis' Relutrigine NDA Review; New PDUFA Date Set For December 27,2026

Regulation & LegislationHealthcare & BiotechCompany FundamentalsAnalyst Insights

Praxis Precision Medicines said the FDA extended the review period for its New Drug Application for relutrigine by three months. The delay suggests added regulatory scrutiny, which may temper near-term approval expectations for the company.

Analysis

Praxis Precision Medicines said the FDA extended the review period for its New Drug Application for relutrigine by three months. The delay suggests added regulatory scrutiny, which may temper near-term approval expectations for the company.

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