3-mo Extension to Relutrigine NDA: We See No Impact To Approvability

研报英文原文证据摘录

3-mo Extension to Relutrigine NDA: We See No Impact To Approvability

TD Cowen Praxis Precision Medicines

Global Research June 29, 2026

AT A GLANCE

Our Investment Thesis Forthcoming Catalysts

Praxis is a clinical stage biopharmaceutical company developing therapies for various CNS 1H26: Ph3 POWER3 monotherapy study start

disorders. Lead asset ulixacaltamide showed compelling, uniformly consistent Ph3 ET data, with of vormatrigine

an NDA accepted and a Jan 29, 2027 PDUFA. As no new ET treatments have been approved

Dec 27, 2026: Relutrigine SCN2A/8A DEE

in over 50 years, and ~50-70% of patients do not respond to first-line SOC propanolol, ulixa is

PDUFA

poised to fulfill a high unmet need. We currently model peak sales of $6.2Bn in 2034.

4Q26: EMERALD all DEEs data of relutrigine

The company's epilepsy pipeline includes vormatrigine (NaV modulator) for FOS, relutrigine

(NaV blocker) for SCN2A/8A DEEs and broad DEEs, and elsunersen (ASO) for SCN2A DEEs, which Jan 29, 2027: Ulixa ET PDUFA

have all shown encouraging POC. The relutrigine SCN2A/8A DEEs NDA was accepted with a Dec

2027: Phase 3 POWER2 FOS data

27th, 2026 PDUFA; we expect approval.

Base Case Assumptions Upside Scenario Downside Scenario

■ Ulixacaltamide receives FDA approval for ■ Ulixacaltamide generates blockbuster ■ Ulixacaltamide does not receive FDA

essential tremor sales in ET approval/shows unexpected safety

■ Vormatrigine succeeds in clinical ■ Vormatrigine receives FDA approval signals that limit its commercial

development for generalized and FOS for generalized and FOS epilepsies and opportunity

epilepsies succeeds commercially ■ Vormatrigine, relutrigine, or elsunersen

■ Relutrigine succeeds in clinical ■ Relutrigine receives FDA approval for show safety signals that impair their