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Roivant gets FDA approval for LISRAYA brepocitinib in dermatomyositis

Roivant Sciences Ltd. said the FDA approved LISRAYA (brepocitinib) 30 mg for adult dermatomyositis following Phase 3 VALOR results showing clinical and functional gains.

ROIV

Roivant Sciences Ltd. (NASDAQ:ROIV) said the FDA approved LISRAYA (brepocitinib) 30 mg for the treatment of adult dermatomyositis after Phase 3 VALOR showed clinical and functional gains. The company also said it will present topline Phase 2 PHocus mosliciguat data for PH—ILD at ERS Congress on Sept 8, 2026.