Two NDAs at FDA simultaneously, both past mid-cycle with no major concerns flagged — approval of either or both validates Praxis's precision epilepsy engine

Praxis Precision Medicines is a clinical-stage rare-disease company with two targeted epilepsy and tremor drugs currently under FDA review, neither yet approved.

Praxis enters late 2026 with two NDAs simultaneously under active FDA review, relutrigine for a devastating childhood epilepsy with no approved therapy and ulixacaltamide for essential tremor, both past mid-cycle with clean safety and efficacy signals. The thesis resolves on whether one or both drugs earn approval, converting $1.4 billion in cash and a commercial infrastructure already being built into a self-sustaining rare-disease franchise. The primary approval risk for relutrigine is the single-arm-adjacent sensitivity-analysis extension that triggered a three-month PDUFA delay, raising the question of whether existing efficacy data withstand FDA's full statistical scrutiny.