Praxis Precision Medicines, Inc.
PDUFA Confirmed
relutrigine
SCN2A/SCN8A-DEE and Broad DEEs
Countdown
83days
FDA decision Β· Sep 27, 2026
What's at stake The FDA's approval decision on relutrigine for SCN2A/SCN8A-DEE and Broad DEEs is due Sep 27, 2026. A green light opens the market; a complete response letter (CRL) usually sinks the stock.
β€œAssuming successful initial NDA approval of relutrigine, the EMERALD study, if positive, would serve as the basis for a supplemental NDA submission in 2027.”

Provenance

5 sources on file.

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