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StocksMediumUpdated×2•Originally published 8 September 2026•Updated 8 September 2026•
2 min read

Roivant Jumps About 20% as Mosliciguat Phase 2 Trial Meets Key Goals

Key Facts

1Mosliciguat reduced pulmonary vascular resistance by 56.3% versus placebo at Week 16, with p<0.0001.
2The 6-minute walk distance improved by 35.2 meters, while NT-proBNP fell 53.2% or 357.7 pg/mL at Week 16.
3PHocus enrolled 135 patients at 87 sites in 20 countries.
4The Phase 3 PHrontier study has begun and targets about 375 patients worldwide.

Roivant (ROIV) shares jumped about 20% in premarket trading on September 8, 2026, after the company reported positive Phase 2 PHocus results for mosliciguat in pulmonary hypertension associated with interstitial lung disease (PH-ILD). The data were presented at the 2026 European Respiratory Society International Congress.

Roivant said the trial met its primary endpoint at Week 16, with mosliciguat producing a 56.3% placebo-adjusted reduction in pulmonary vascular resistance, statistically significant at p<0.0001.

For the secondary endpoints at Week 16, 6-minute walk distance improved by 35.2 meters versus placebo at p=0.0027. NT-proBNP, a marker of cardiac strain, fell by 53.2%, or 357.7 pg/mL, at p=0.0002.

A prespecified exploratory analysis at Week 24 showed the placebo-adjusted walking-distance benefit widening to 52.7 meters, while NT-proBNP declined by 75.9%, or 487.1 pg/mL, with nominal p<0.0001 for both results. Because these findings were exploratory, they still require confirmation in a larger trial.

PHocus was a global, randomized, double-blind, placebo-controlled study involving 135 patients at 87 sites in 20 countries, with a 24-week controlled period. That design gives the findings more weight than an open-label study, while the results remain company-reported Phase 2 data.

The company said mosliciguat, a once-daily inhaled sGC activator, was well tolerated. Cough occurred in 12.1% of mosliciguat patients versus 18.2% on placebo, although the safety database remains limited by the study’s size and duration.

Pulmonary vascular resistance measures how difficult it is for blood to move through the lung vessels, while the walking test reflects functional capacity and NT-proBNP indicates cardiac strain. The market reaction therefore followed improvement across a hemodynamic measure, a functional measure and a biomarker rather than a single result.

Roivant has started the Phase 3 PHrontier study and opened enrollment, targeting about 375 patients worldwide. Its ability to confirm efficacy and detect less common adverse reactions is the next focus: Phase 2 success is not regulatory approval, and Phase 3 evidence and regulatory review remain necessary before any potential launch.