Praxis Precision Medicines, Inc. - 8-K Filing
Praxis Precision Medicines announced that the FDA extended its review period for relutrigine's NDA by three months, setting a new PDUFA target action date of December 27, 2026. The extension followed submission of additional sensitivity analyses deemed a 'major amendment' and no new clinical studies or safety concerns were requested. (Items: 8.01 Other Events)
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