Roivant Sciences (ROIV) said Thursday the FDA approved LISRAYA for adults with dermatomyositis, with the once-daily pill now available in the US, sending its shares up 1.5%.
The approval follows the Phase 3 VALOR trial, which showed improvements across disease activity, skin disease, muscle strength and physical function, alongside reduced steroid use.
Roivant said the approval provides a new treatment option for adults with dermatomyositis and is continuing to advance brepocitinib in non-infectious uveitis, cutaneous sarcoidosis and lichen planopilaris.
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