PRAXIS PRECISION MEDICINES INC · Data as of 2026-09-08
Q4 2026
Topline results are anticipated in the fourth quarter of 2026 and assuming successful initial NDA approval of relutrigine, the EMERALD study, if positive, would serve as the basis for a supplemental NDA submission in 2027.Source filing
Dec 27
Following the submission of additional sensitivity analyses of existing clinical data, which the FDA deemed collectively to be a major amendment, the FDA extended the review period for relutrigine's NDA for the treatment of SCN2A and SCN8A DEEs and set a new PDUFA target action date of December 27, 2026.Source filing
2027
Enrollment in the EMBRAVE3 registrational trial is progressing, with topline results expected in 2027.Source filing
2027
Assuming successful initial NDA approval of relutrigine, the EMERALD study, if positive, would serve as the basis for a supplemental NDA submission in 2027.Source filing
2027
POWER2, the second Phase 3 study for vormatrigine in FOS, is enrolling patients, with completion expected in the second half of 2026 and topline results anticipated in 2027.Source filing
2027
If the POWER1 and POWER2 studies are positive, we plan to submit an NDA for vormatrigine in 2027.Source filing
Jan 29
NDA review is progressing as expected, with a PDUFA date of January 29, 2027.Source filing