Recent Updates — ROIV
Roivant Sciences announced positive Phase 2 PHocus clinical trial results for mosliciguat, an inhaled sGC activator, treating pulmonary hypertension associated with interstitial lung disease (PH-ILD). The study met its primary endpoint with a statistically significant placebo-adjusted reduction in pulmonary vascular resistance of -56.3% at Week 16. Secondary endpoints showed a +35.2-meter improvement in six-minute walk distance and a -53.2% reduction in NT-proBNP biomarkers. Mosliciguat demonstrated a favorable safety profile with lower cough incidence than placebo. Roivant has initiated the Phase 3 PHrontier study to further evaluate the drug. Roivant Sciences Ltd. is a commercial-stage biopharmaceutical company that develops and commercializes medicines through nimble subsidiaries.
Roivant Sciences Ltd. announced that the U.S. Food and Drug Administration approved LISRAYA (brepocitinib) for the treatment of adults with dermatomyositis. The company launched the drug commercially immediately upon approval, approximately five weeks ahead of its previous guidance to address significant unmet medical need. The wholesale acquisition cost is set at $35,000 for a 30-count bottle of 30 mg tablets. Roivant operates in the biopharmaceutical industry, developing and commercializing treatments through its network of subsidiary companies.
Roivant Sciences Ltd. announced that the U.S. Food and Drug Administration approved the New Drug Application for LISRAYA (brepocitinib) 30 mg for the treatment of adults with dermatomyositis. Submitted by subsidiary Priovant Therapeutics, Inc., this approval marks the first targeted therapy for this rare autoimmune disease. The decision followed the Phase 3 VALOR trial, which demonstrated significant improvements in skin disease, muscle strength, and physical function alongside substantial steroid-sparing benefits. LISRAYA is available immediately in the U.S. through a limited distribution network of specialty pharmacies. Roivant Sciences Ltd. operates as a biopharmaceutical company that develops and commercializes medicines.
Roivant Sciences Ltd. reported financial results for the first quarter ended June 30, 2026, on August 6, 2026. The company posted a net loss of $189.8 million, or $0.26 per share, compared to a net loss of $223.4 million in the prior year period. R&D expenses rose to $202.0 million and G&A expenses increased to $165.5 million, largely driven by bonuses related to a global patent infringement settlement with Moderna. Roivant recognized a gain on litigation settlement of $392 thousand. The company held $3.9 billion in cash and marketable securities as of June 30, 2026. During the quarter, Roivant repurchased 7.3 million common shares for approximately $208.7 million. Commercial preparations for brepocitinib in dermatomyositis are on track for a September 2026 launch, with first patients enrolled in a Phase 3 study for cutaneous sarcoidosis. Roivant Sciences Ltd. is a biopharmaceutical company that develops and commercializes medicines through specialized subsidiaries.