Roivant Sciences Reports Positive Phase 2 PHocus Results for Mosliciguat in PH-ILD

Summary of Clinical & Regulatory Developments

On September 8, 2026, Roivant Sciences Ltd. (NASDAQ: ROIV) furnished a Current Report on Form 8-K disclosing positive topline results from its global Phase 2 PHocus clinical trial evaluating mosliciguat for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD).

Key Clinical Findings (Phase 2 PHocus)

• Primary Endpoint: Achieved a statistically significant, placebo-adjusted reduction in pulmonary vascular resistance (PVR) of -56.3% (p < 0.0001) at Week 16 (-51.3% for mosliciguat vs. +6.6% for placebo).
• Secondary Endpoints (Week 16):
  • 6MWD: Placebo-adjusted improvement of +35.2 meters (p = 0.0027).
  • NT-proBNP: Placebo-adjusted reduction of -53.2% (-357.7 pg/mL, p = 0.0002).
• Exploratory Analysis (Week 24): Placebo-adjusted 6MWD improvement widened to +52.7 meters (nominal p < 0.0001) and NT-proBNP reduction reached -75.9% (-487.1 pg/mL, nominal p < 0.0001).
• Safety & Tolerability: Well-tolerated overall, with lower incidence of cough compared to placebo (12.1% vs. 18.2%), differentiating it favorably from inhaled prostacyclins.

Pipeline & Regulatory Next Steps

• Phase 3 PHrontier Study: Roivant subsidiary Pulmovant, Inc. has officially initiated enrollment for the global, double-blind Phase 3 PHrontier trial, planned to enroll ~375 adult patients with PH-ILD.
• Presentation: Full study results are being presented at the European Respiratory Society (ERS) International Congress 2026.