Roivant Sets Sept. 8 PHocus Topline Readout and Investor Call for Mosliciguat

Roivant Sciences and its Pulmovant subsidiary set September 8 for the topline Phase 2 PHocus readout of mosliciguat in pulmonary hypertension associated with interstitial lung disease, giving investors a firm date for one of the clinical milestones Roivant had guided to for the second half of 2026.

The companies said on September 6 that the results will be presented at the European Respiratory Society International Congress at 12:15 p.m. CEST, or 6:15 a.m. ET, by Marc Humbert, professor of respiratory medicine at Université Paris-Saclay and director of the French National Reference Center for Pulmonary Hypertension. Roivant will then hold an investor call and webcast at 8:00 a.m. ET. The announcement itself did not disclose the PHocus results.

Roivant had previously guided to topline mosliciguat data in the second half of 2026. Fixing the presentation date narrows that timing to a specific near-term event and shifts the focus from when the data will arrive to what the randomized study shows in patients with PH-ILD.

What PHocus is designed to show

PHocus is a randomized, double-blind, placebo-controlled Phase 2 study sponsored by Pulmovant. The ClinicalTrials.gov record lists actual enrollment of 135 adults, making the study somewhat larger than the roughly 120-patient plan Roivant described when it first unveiled mosliciguat in 2024.

Participants were assigned to once-daily inhaled mosliciguat or placebo during a 24-week blinded treatment period. Those who complete that portion can continue into an extension in which all participants receive mosliciguat. The study began on October 29, 2024 and is listed as active but not recruiting.

The primary outcome is the change from baseline to Week 16 in pulmonary vascular resistance, measured by right-heart catheterization. Pulmonary vascular resistance, or PVR, reflects resistance to blood flow through the pulmonary circulation and is a central hemodynamic measure in pulmonary hypertension. Secondary measures at Week 16 include distance achieved on the six-minute walk test and changes in NT-proBNP, a blood biomarker associated with cardiac strain and right-heart function.

Those endpoints matter because PH-ILD combines pulmonary hypertension with underlying interstitial lung disease. The condition can limit exercise capacity and place additional stress on the right side of the heart. PHocus therefore has to answer more than whether mosliciguat can alter a catheter-based hemodynamic measure. The secondary measures will add evidence on whether any PVR effect is accompanied by changes in functional capacity or a cardiac biomarker.

The ClinicalTrials.gov record still lists estimated primary completion in December 2026 and study completion in January 2028. That is not necessarily inconsistent with a September topline presentation because the registered protocol includes the 24-week blinded period and a longer extension. Tuesday’s readout should be treated as a development milestone for the program, not as the formal completion of every part of PHocus.

Mosliciguat’s earlier signal came from a different PH population

Roivant introduced mosliciguat publicly in September 2024 after Pulmovant presented results from the Phase 1b ATMOS study. Mosliciguat is an inhaled soluble guanylate cyclase, or sGC, activator delivered through a dry-powder inhaler. Roivant has promoted once-daily dosing and targeted lung delivery as potential advantages, but those claims still depend on later-stage data to establish how the drug performs in its intended PH-ILD population.

ATMOS was a non-randomized, open-label, single-dose study in 38 patients with Group 1 pulmonary arterial hypertension or Group 4 chronic thromboembolic pulmonary hypertension, not PH-ILD. In the per-protocol set of 20 patients, Roivant reported mean maximum PVR reductions from baseline of 25.9% at 1.0 mg, 38.1% at 2.0 mg and 36.3% at 4.0 mg. The company also said its broader Phase 1 program had dosed 170 healthy volunteers and pulmonary-hypertension patients.

Those Phase 1b findings supplied the rationale for moving into PHocus, but they cannot establish the Phase 2 outcome in advance. ATMOS used different pulmonary-hypertension populations, had no placebo control and assessed a single dose. PHocus is designed to test repeated treatment in PH-ILD under randomized, blinded conditions, so the September 8 data will provide a materially stronger test of both efficacy and safety in the target disease setting.

Pulmovant holds exclusive worldwide rights to develop and commercialize mosliciguat under a license from Bayer. When Roivant disclosed the program in 2024, it said Bayer had received about $14 million upfront and could receive up to another $280 million in development, regulatory and commercial milestone payments, plus tiered high-single-digit royalties on sales. That structure gives the clinical program direct financial relevance if mosliciguat advances.

The readout comes in a market with an established PH-ILD therapy

Mosliciguat is not entering an untreated regulatory category. The FDA approved United Therapeutics’ inhaled treprostinil, Tyvaso, for PH-ILD in 2021 to improve exercise ability, and approved the dry-powder Tyvaso DPI formulation in 2022 for pulmonary arterial hypertension and PH-ILD. That existing option raises the bar for a new entrant because investors will look not only for a positive result, but also for evidence that mosliciguat could offer a useful clinical or administration profile.

In investor materials, Roivant has emphasized a once-daily dry-powder regimen and has used cross-study PVR comparisons to describe the drug’s potential. Those comparisons are not head-to-head evidence. Roivant itself has cautioned that differences in study design and patient characteristics limit direct comparisons across trials, making the controlled PHocus dataset especially important.

The program is also arriving at a time when Roivant has substantial resources to fund development. The company reported $3.9 billion of consolidated cash, restricted cash and marketable securities as of June 30, 2026, excluding a subsequent Moderna settlement payment received in July. Research and development expense was $202.0 million for the June quarter, and Roivant said higher program-specific costs included a $4.7 million increase related to mosliciguat as development progressed.

The next hard information point is now fixed. Humbert is scheduled to present the PHocus topline results at 12:15 p.m. CEST on September 8, followed by Roivant’s investor call at 8:00 a.m. ET. The company said presentation and webcast details will be available through its investor website, with an archived webcast available after the call.