Praxis Completes Relutrigine Commercial Team During FDA Review

The Tip Desk · November 9, 2026 · 3 min read

Cash and investments stood at about $1.3 billion as of September 30, 2026, with a net loss of $94.2 million in the third quarter.

Praxis Precision Medicines, Inc. (PRAX), a fully integrated central nervous system precision neuroscience biopharmaceutical company, said the commercial team for relutrigine is fully hired as the Food and Drug Administration continues review of the drug’s new application, with a PDUFA target action date of December 27, 2026.

The company also said it expects the ulixacaltamide sales force to be in place in the fourth quarter of 2026, with that NDA’s PDUFA date remaining January 29, 2027. President and chief executive officer Marcio Souza said the company is entering a defining period with two key regulatory milestones ahead and the opportunity to become a commercial CNS company.

Relutrigine’s review clock had already been reset in the second-quarter update after the FDA extended the period following additional sensitivity analyses it deemed a major amendment, moving the target from the originally accepted September 27, 2026 date. The third-quarter release restated the December 27 date and described launch preparations as well advanced, with the commercial team fully hired. If approved, relutrigine would be the first therapy for SCN2A and SCN8A developmental and epileptic encephalopathies and would be eligible for a Pediatric Review Voucher.

Ulixacaltamide for essential tremor remains under FDA review on the same January 29, 2027 timeline. Commercial leadership is in place, and hiring of the field sales force is expected to be completed in the fourth quarter. Praxis reinitiated the long-term safety study associated with the Essential3 program to give eligible patients an opportunity to participate ahead of potential commercial availability. In July 2026 the company began a collaboration with Remagine Labs to develop a transdermal patch of ulixacaltamide for essential tremor.

The EMERALD study of relutrigine in broad DEEs is in the final stages of completion, with topline results expected in the fourth quarter of 2026. The POWER2 study of vormatrigine restarted after design updates that incorporated learnings from POWER1. Praxis said it continues to review the design of POWER3, a planned vormatrigine monotherapy study it expects to initiate in 2027. Enrollment in the EMBRAVE3 registrational trial of elsunersen continues, with topline results anticipated in 2027.

Cash, cash equivalents and marketable securities were $1.3 billion as of September 30, 2026, compared with $926.1 million as of December 31, 2025. The company said the $359.9 million increase was primarily attributable to net proceeds from a January 2026 follow-on public offering and interest income, partially offset by cash used in operations, and that the cash balance is expected to fund operations into 2028. Shares outstanding were 27.9 million as of September 30, 2026.

Research and development expenses were $64.2 million for the third quarter of 2026, down $1.6 million from $65.8 million a year earlier. The company said the decrease was primarily attributable to $8.8 million in lower Cerebrum-related expenses, partially offset by $7.0 million in higher personnel-related costs. General and administrative expenses were $42.7 million, up $30.1 million from $12.6 million in the third quarter of 2025. Praxis attributed the increase primarily to $17.2 million in higher personnel-related expenses, $9.4 million in higher professional expenses and $3.5 million in other expenses.

The company incurred a net loss of $94.2 million for the third quarter of 2026, including $14.9 million of stock-based compensation expense, compared with a net loss of $73.9 million in the third quarter of 2025, including $7.4 million of stock-based compensation.

Praxis will host an in-person and virtual Investor Day on November 12, 2026, with presentations on commercial strategy and launch readiness for the two programs under FDA review and on the development pipeline.