Praxis Precision reports Q3 EPS ($3.36), consensus ($3.49)

Reports Q3 revenue $0, consensus $59,440. “It’s been a monumental few months for us at Praxis, culminating in the first ever successful Phase 3 program of an investigational drug in ET, with both studies in the Essential3 program meeting their primary endpoints. Ulixacaltamide demonstrated significant improvements in symptoms that are not only clinically meaningful but also change patients’ lives. We have been granted a pre-NDA meeting with the FDA and look forward to discussing Praxis’ first NDA submission,” said Marcio Souza, president and chief executive officer. “Leveraging our breakthrough therapy designation for relutrigine, we completed comprehensive discussions with the FDA to perform an interim analysis of our EMBOLD study in Q4 which, if successful, supports another potential NDA submission for relutrigine in SCN2A/8A DEEs in early 2026. For our vormatrigine program, following the positive results from the first cohort of the RADIANT study, we have now completed recruitment for POWER1 with expected readout in the first half of 2026, and POWER2 is underway and planning to be fully enrolled in the second half of 2026. With the recently completed public offering, we are well-positioned to continue executing across our robust portfolio as we prepare for our first commercial launch, establishing Praxis as the leader in innovative therapies for CNS disorders.”