Full Breakdown
Roivant’s Mosliciguat Shows Strong Phase 2 Results in PH-ILD
9/9/2026, 1:39:04 AM
Core Findings from the Phase 2 PHocus Trial
Roivant Sciences announced that its inhaled soluble guanylate cyclase activator mosliciguat met the primary endpoint of reducing pulmonary vascular resistance (PVR) in patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD). The trial reported a placebo-adjusted PVR decline of -56.3%, while the placebo group showed a +6.6% change. Secondary measures also improved, with a 35.2-meter increase in six-minute walk distance and a 357.7 pg/mL reduction in NT-proBNP at Week 16. The drug was generally well tolerated, with cough reported in 12.1% of treated patients versus 18.2% on placebo.
Background and Development Path
Mosliciguat was acquired from Bayer in a 2024 transaction valued at up to $294 million and is being advanced by Roivant’s subsidiary Pulmovant under the company’s hub-and-spoke biotech model. The candidate follows Roivant’s first FDA approval—Lisraya for an autoimmune skin disease—earned by another subsidiary, Priovant, last month. PH-ILD currently has only one approved therapy, United Therapeutics’ Tyvaso (expanded indication 2021), leaving a substantial unmet need.
Data & Statistics
- PVR reduction: -56.3% (mosliciguat) vs +6.6% (placebo)
- Six-minute walk gain: +35.2 m (mosliciguat)
- NT-proBNP decline: –357.7 pg/mL (mosliciguat)
- Cough incidence: 12.1% (mosliciguat) vs 18.2% (placebo)
- Stock reaction: Roivant shares rose >14%, opening around $39.99 per share.
Official Statements & Responses
Analysts at Leerink Partners described the outcome as a “blowout,” saying the trial “significantly exceeded expectations” of at least a 20% PVR reduction and positioning the drug well apart from existing options.
Verbatim Quotes
- “PH-ILD is a disease as bad as some forms of cancer, with a median survival of just 1.5-2 years despite best-available standard of care,” — Mayukh Sukhatme, president and chief investment officer at Roivant
