Roivant's experimental inhaled drug mosliciguat met its primary Phase 2 goals, reducing pulmonary vascular resistance by 56.3% in patients with pulmonary hypertension associated with interstitial lung disease. The positive trial results sent Roivant shares up 20% on September 8, 2026. Roivant has already initiated a Phase 3 study aiming to enroll 375 patients globally, potentially offering a new treatment pathway alongside existing therapies like Tyvaso.
Mosliciguat Phase 2 results
- ▪The Phase 2 trial of mosliciguat enrolled 135 patients across 87 sites in 20 countries, with therapeutic benefits continuing through Week 24
- ▪Roivant's experimental drug mosliciguat met the primary goal of a Phase 2 study by reducing pulmonary vascular resistance by 56.3% compared to placebo after 16 weeks of treatment
- ▪In the Phase 2 study of mosliciguat, the drug met secondary goals, showing a 35.2-meter placebo-adjusted improvement in a six-minute walking test and a 53.2% reduction in a heart-strain blood marker after 16 weeks
Pulmonary hypertension treatment
- ▪Roivant's inhaled drug candidate mosliciguat, which the company acquired from Bayer, is designed to treat pulmonary hypertension associated with interstitial lung disease
- ▪Pulmonary hypertension develops in patients with interstitial lung disease when scarring damages blood vessels in the lungs, forcing the heart to work harder to pump blood
Roivant stock surge
- ▪Roivant expanded its late-stage pipeline after receiving U.S. approval in August 2026 for its skin and muscle disease treatment Lisraya
- ▪Roivant shares surged approximately 20% in premarket trading on September 8, 2026, following the announcement of positive Phase 2 results for mosliciguat
Existing treatment options
- ▪Off-label treatments for pulmonary hypertension associated with interstitial lung disease include PDE5 inhibitors such as Viatris' Viagra and Lilly's Cialis
- ▪Current treatment options for pulmonary hypertension associated with interstitial lung disease include inhaled treprostinil products such as United Therapeutics' Tyvaso and Tyvaso DPI, and Liquidia's Yutrepia
Late-stage trial enrollment
- ▪Roivant plans to enroll approximately 375 patients worldwide in its late-stage study of mosliciguat
- ▪Roivant has initiated a late-stage Phase 3 study for its experimental lung disease drug mosliciguat
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