FDA Approves Priovant's Lisraya for Dermatomyositis

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Summary · why it matters

Priovant Therapeutics, backed by Pfizer and Roivant Sciences, has received FDA approval for its lead asset, Lisraya (brepocitinib), for the treatment of dermatomyositis, a rare autoimmune disorder. The once-daily 30 mg pill is now available immediately in the U.S. as the first and only targeted therapy for this condition. The approval is based on data from the Phase 3 VALOR trial, which showed improvements across multiple disease areas as early as week four, sustained through the 52-week study. The TYK2/JAK1 inhibitor will be distributed through a limited network of specialty pharmacies, following a priority review granted in March with a target action date in Q3 2026.

Impact on stocks 2

Biotech & Genomic Medicine▲ · 2 stocks
Roivant Sciences Ltd
ROIV
▲ PositiveRegulationrelevance

Roivant Sciences-backed Priovant received FDA approval for Lisraya, its lead asset for dermatomyositis.

Pfizer Inc
PFE
▲ PositiveRegulationrelevance

FDA approval of Lisraya, developed by Pfizer-backed Priovant, is a positive regulatory milestone for an asset Pfizer has a stake in.

Theme Impact 1

Off-coverage companies 1

Priovant TherapeuticsPrivate▲ Positive
Regulationrelevance

Priovant Therapeutics received FDA approval for its lead asset Lisraya (brepocitinib) for dermatomyositis, the first targeted therapy for the condition.

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