Praxis Relutrigine PDUFA Date Moved to December 27, 2026
Praxis's relutrigine PDUFA date moved from September 27 to December 27, 2026. The June 29 company announcement and SEC filing confirm the FDA review extension.
This article records evidence available when published or updated. Registration dates are not proof of trial enrollment; check the original sources for current status.
Correction, September 23, 2026: An earlier version of this article described September 27, 2026 as an upcoming FDA action date. That was wrong. Praxis announced on June 29, 2026 that the FDA had moved the target date to December 27, 2026. The September date remains in this page's URL so readers following the original link can find the correction.
What changed
Praxis Precision Medicines said the FDA extended the review period for the relutrigine New Drug Application by three months. The target action date moved from September 27 to December 27, 2026. The application concerns treatment of SCN2A and SCN8A developmental and epileptic encephalopathies (DEEs). The company disclosed the change on June 29, 2026 in both its press release and Form 8-K.
Praxis said the extension followed its submission of additional sensitivity analyses of existing clinical data, which the FDA treated as a major amendment. According to that disclosure, the FDA did not request new clinical studies and did not cite safety or manufacturing concerns. These are the company's statements about the review; they do not determine its outcome.
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Praxis Relutrigine PDUFA Date Moved to December 27, 2026: which company evidence supports or challenges the article?
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What readers should track now
The currently disclosed PDUFA target action date for relutrigine is December 27, 2026, subject to any later official update. An action date is a review target, not an approval. The FDA's eventual decision and timing remain unknown until a reliable source reports them.
Our original article treated an older April filing's September 27 date as current even though the June 29 extension was already available in our source data. It also described the September and December dates as separate relutrigine regulatory events. They refer to one application with a revised target date. We have corrected the article and linked it to the December 27 event in our calendar: Praxis company page · updated relutrigine event.
Primary sources: Praxis June 29 announcement; Praxis June 29 SEC Form 8-K.