Roivant Sciences Ltd. 8K

Roivant reported strong positive Phase 2 PHocus results for mosliciguat in PH-ILD and announced the initiation and ongoing enrollment of its Phase 3 PHrontier trial.

On September 8, 2026, Roivant (Nasdaq: ROIV) announced that its Phase 2 PHocus trial of mosliciguat in patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD) met its primary and secondary endpoints, showing a 56.3% placebo-adjusted reduction in pulmonary vascular resistance at Week 16, significant improvements in six-minute walk distance and NT-proBNP levels, and a favorable safety profile with lower cough incidence than placebo, and simultaneously disclosed that it has initiated and begun enrolling patients in the global Phase 3 PHrontier study while presenting the data at the European Respiratory Society International Congress 2026 and hosting an investor call to discuss the results and development plans.

Filing Facts

CIK

1635088

Ticker

ROIV

Form

8K

Source Type

fda

Accession

0001140361-26-035859

Alert Tier

7