Regulatory2026-09-30

Brepocitinib - (VALOR)

Pfizer Inc.PFE
Indication
Dermatomyositis (DM)
Stage
phase5
Event
Regulatory Decision
Details

April 2, 2026: Priovant announced a new seamless Phase 2b/3, potentially registrational trial of brepocitinib (dual JAK1/TYK2 inhibitor) in lichen planopilaris (LPP), an inflammatory scarring alopecia with no FDA-approved therapies. The trial began enrollment and enrolled its first subjects in March 2026. The company cited mechanistic rationale and clinically meaningful results from an investigator-initiated, placebo-controlled study in LPP as supporting rapid development (no specific efficacy numbers provided).

Brepocitinib broader late-stage catalysts noted:

  • Dermatomyositis (DM): FDA granted Priority Review for the NDA; PDUFA target action date set for 3Q 2026. The company also referenced an expected product launch in DM in September (year not specified).
  • Non-infectious uveitis (NIU): topline Phase 3 data expected in 2H 2026.
  • Cutaneous sarcoidosis (CS): Phase 3 study initiation expected in 2H 2026.

Priovant is a Roivant (NASDAQ: ROIV) company.