Roivant to unveil mosliciguat Phase 2 PH-ILD data at ERS 2026

Topline results from the PHocus study will be presented at the European Respiratory Society Congress on 8 September, followed by an investor call.

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A medical device with a dark screen and clear tubes rests on a white table in a brightly lit room, with a blurred window and a chair visible in the background.

Roivant Sciences and its subsidiary Pulmovant will present topline data from the Phase 2 PHocus study of mosliciguat at the European Respiratory Society International Congress 2026 on 8 September, with an investor call and webcast scheduled for the same day at 8:00 a.m. ET.

The presentation will be delivered by Marc Humbert, Professor of Respiratory Medicine at Université Paris-Saclay and Director of the French National Reference Center for Pulmonary Hypertension, at 12:15 CEST. Humbert is a widely published figure in the pulmonary hypertension field and his involvement as the presenting investigator lends the readout additional scientific credibility.

The candidate and the indication

Mosliciguat is an inhaled soluble guanylate cyclase (sGC) activator being developed for pulmonary hypertension associated with interstitial lung disease, a subset of pulmonary hypertension that has historically been difficult to treat and has limited approved options. PH-ILD is classified as Group 3 pulmonary hypertension under the World Health Organization's clinical classification, a category distinct from Group 1 pulmonary arterial hypertension, which carries most of the approved pharmacotherapy.

That regulatory distinction matters. The FDA approved inhaled treprostinil (Liquidia's Yutrepiion and United Therapeutics' Tyvaso DPI) specifically for PH-ILD following the landmark INCREASE trial, establishing that the indication can support a dedicated approval pathway. Mosliciguat's mechanism as an sGC activator differs from prostacyclin-pathway agents; if PHocus data show haemodynamic or functional benefit, Roivant would have a scientific rationale for a differentiated label claim.

Competitive and regulatory context

The PH-ILD space has attracted growing interest precisely because Group 3 patients were excluded from most pivotal trials underpinning Group 1 approvals. Beyond prostacyclin analogues, Merck's riociguat, an sGC stimulator, is approved for Group 1 and Group 4 pulmonary hypertension but carries a black-box warning against use in PH-ILD after the RISE-IIP trial showed harm in that population. Mosliciguat is an sGC activator rather than a stimulator, a mechanistic distinction the company has argued confers a different safety and activity profile in hypoxic conditions typical of ILD.

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