earnings
confidence high
sentiment positive
materiality 0.80
Praxis Q2 net loss $83.7M; FDA mid-cycle positive for ulixacaltamide and relutrigine; no AdCom
Praxis Precision Medicines, Inc.
2026-Q2 EPS
reported -$6.08
vs consensus -$3.73
▼ miss
(-62.8%)
- FDA mid-cycle meetings for ulixacaltamide (ET) and relutrigine (DEEs) found no major safety/efficacy concerns; no advisory committee planned; PDUFA dates Jan 29, 2027 and Dec 27, 2026.
- BIMO inspections for both NDAs completed with no Form 483 observations.
- Third Breakthrough Therapy Designation granted for elsunersen in SCN2A DEE (gain-of-function).
- Q2 2026 net loss $83.7M; cash $1.4B, runway into 2028.
- Vormatrigine POWER1 missed primary endpoint but met secondary; plans to restart POWER2 and start POWER3 in Q4 2026.