Praxis reports Q3 2026 results, two NDAs still under FDA review

Praxis Precision Medicines reported its third quarter 2026 results on November 9, 2026. The company said FDA review continues for both of its lead candidates: the NDA for relutrigine for SCN2A and SCN8A DEEs carries a PDUFA target action date of December 27, 2026¹, while the ulixacaltamide NDA has a PDUFA target action date of January 29, 2027¹.

On the pipeline, the EMERALD study in broad DEEs is in the final stages of completion¹, with topline data still slated for the fourth quarter of 2026 per the release's headline items. In epilepsy, the POWER2 study resumed after design changes that drew on findings from the POWER1 Phase 2/3 trial¹, and the company said it is still reviewing the design of POWER3, a planned monotherapy study of vormatrigine, which it expects to start in 2027¹. For the ASO program, enrollment in the EMBRAVE3 registrational trial is described as progressing, with topline results anticipated in 2027¹.

On commercial readiness, the company said launch preparations for relutrigine are well advanced with its commercial team fully hired¹, and it expects to finish hiring its ulixacaltamide field sales force in the fourth quarter of 2026¹. Praxis also noted a July 2026 collaboration with Remagine Labs to develop a transdermal patch formulation of ulixacaltamide intended to expand treatment options and support the franchise long term¹.

On finances, Praxis held $1.3 billion in cash, cash equivalents and marketable securities as of September 30, 2026, up from $926.1 million at the end of 2025¹. The company attributed much of the increase to proceeds from a January 2026 stock offering and interest income, offset partly by operating cash use, and said the balance is expected to fund operations into 2028, per the release.