Roivant Sciences shares surged as much as 24% in Tuesday trading after the company's Pulmovant subsidiary announced that its experimental inhaled drug mosliciguat achieved a clinically meaningful and statistically significant result in a Phase 2 trial for patients with pulmonary hypertension associated with interstitial lung disease, a progressive and life-threatening condition with few approved treatments.
The Phase 2 PHocus study, a randomized, double-blind, placebo-controlled trial that enrolled 135 adult participants across 87 sites in 20 countries, found that mosliciguat produced a placebo-adjusted reduction in pulmonary vascular resistance of 56.3% at week 16, according to the company's announcement. The drug met both its primary and secondary endpoints.
Results were formally presented Tuesday morning at the European Respiratory Society International Congress 2026 in Amsterdam by Marc Humbert, a professor of respiratory medicine at Université Paris-Saclay and director of the French National Reference Center for Pulmonary Hypertension. Roivant also hosted an investor call and webcast at 8 a.m. Eastern time to walk analysts through the data and its plans for late-stage development.
Mosliciguat is an inhaled soluble guanylate cyclase activator dosed once daily, designed to relax and widen blood vessels in the lungs to reduce the strain on the heart caused by pulmonary hypertension. The company said the drug was generally well tolerated, with a notably lower rate of cough, a common tolerability issue with inhaled therapies in this class, compared with placebo.
Roivant said a Phase 3 confirmatory trial, dubbed PHrontier, has already been initiated and is actively enrolling patients, a signal to investors that the company intends to move quickly toward a potential regulatory filing rather than pursuing additional mid-stage studies. Pulmonary hypertension associated with interstitial lung disease currently has limited approved treatment options, and analysts have flagged the indication as a significant unmet medical need with meaningful commercial potential if mosliciguat can replicate the Phase 2 results in a larger trial population.
The rally adds to a mixed year for Roivant, which has separately advanced other pipeline assets including LISRAYA (brepocitinib), a JAK1/TYK2 inhibitor already approved for dermatomyositis and in late-stage testing for additional autoimmune indications. Some investors noted that recent insider selling at Roivant, including roughly 1.4 million shares sold with no offsetting purchases, will likely be viewed in a different light following Tuesday's positive readout. The stock's move was among the largest single-day gains for any mid-cap biopharmaceutical name so far this quarter.